Interactive surgical systems with condition handling of devices and data capabilities

ABSTRACT

A surgical hub is configured to authenticate data communications with surgical devices. The surgical hub comprises a processor and a memory storing instructions executable by the processor to: transmit a public key to a detected surgical device; receive a message from the surgical device encrypted using the public key associated with the surgical hub, the encrypted message comprising a shared secret associated with the surgical device and a checksum function associated with the shared secret, wherein the shared secret comprises an identifier assigned to the surgical device; decrypt the encrypted message, using a private key associated with the public key, to reveal the shared secret and the checksum function; receive data communications from the surgical device encrypted using the shared secret, and comprising a checksum value, derived via the checksum function, based on the data communications; and decrypt the data communications using the shared secret.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. 119(e)to U.S. Provisional Patent Application Ser. No. 62/649,302, titledINTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES,filed on Mar. 28, 2018, the disclosure of which is herein incorporatedby reference in its entirety.

This application also claims the benefit of priority under 35 U.S.C.119(e) to U.S. Provisional Patent Application Ser. No. 62/611,341,titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, of U.S.Provisional Patent Application Ser. No. 62/611,340, titled CLOUD-BASEDMEDICAL ANALYTICS, filed Dec. 28, 2017, of U.S. Provisional PatentApplication Ser. No. 62/611,339, titled ROBOT ASSISTED SURGICALPLATFORM, filed Dec. 28, 2017, the disclosure of each of which is hereinincorporated by reference in its entirety.

BACKGROUND

The present disclosure relates to various surgical systems. Surgicalprocedures are typically performed in surgical operating theaters orrooms in a healthcare facility such as, for example, a hospital. Asterile field is typically created around the patient. The sterile fieldmay include the scrubbed team members, who are properly attired, and allfurniture and fixtures in the area. Various surgical devices and systemsare utilized in performance of a surgical procedure.

SUMMARY

In one general aspect, a surgical hub is provided. The surgical hub isconfigured to authenticate data communications with surgical devices.The surgical hub comprises a processor and a memory coupled to theprocessor. The memory stores instructions executable by the processorto: detect that a surgical device is communicatively coupled to thesurgical hub; transmit a public key associated with the surgical hub tothe surgical device; and receive a message from the surgical device. Themessage is encrypted using the public key associated with the surgicalhub. The encrypted message comprises a shared secret associated with thesurgical device and a checksum function associated with the sharedsecret. The shared secret comprises an identifier assigned to thesurgical device. The instructions executable by the processor alsodecrypt the encrypted message, using a private key associated with thetransmitted public key, to reveal the shared secret and the checksumfunction; receive data communications from the surgical device; anddecrypt each data communication using the shared secret until thesurgical device is decoupled from the surgical hub. Each datacommunication is encrypted using the shared secret received from thesurgical device. Each data communication comprises a checksum value,derived via the checksum function, based on the data of each receivedcommunication. The integrity of each data communication is verifiablebased on its associated checksum value.

In another general aspect, another surgical hub is provided. Thesurgical hub is configured to authenticate data communications withsurgical devices. The surgical hub comprises a control circuitconfigured to: detect that a surgical device is communicatively coupledto the surgical hub; transmit a public key associated with the surgicalhub to the surgical device; and receive a message from the surgicaldevice. The message is encrypted using the public key associated withthe surgical hub. The encrypted message comprises a shared secretassociated with the surgical device and a checksum function associatedwith the shared secret. The shared secret comprises an identifierassigned to the surgical device. The control circuit configured to alsodecrypt the encrypted message, using a private key associated with thetransmitted public key, to reveal the shared secret and the checksumfunction; receive data communications from the surgical device; anddecrypt each data communication using the shared secret until thesurgical device is decoupled from the surgical hub. Each datacommunication is encrypted using the shared secret received from thesurgical device. Each data communication comprises a checksum value,derived via the checksum function, based on the data of each receivedcommunication. The integrity of each data communication is verifiablebased on its associated checksum value.

In yet another general aspect, another surgical hub is provided. Thesurgical hub is configured to authenticate surgical devices coupled tothe surgical hub. The surgical hub comprises a processor and a memorycoupled to the processor. The memory stores instructions executable bythe processor to: detect that a surgical device is communicativelycoupled to the surgical hub; receive an encrypted identifier and asource ID from the surgical device; transmit a first message from thesurgical hub to a server of a surgical device manufacturer associatedwith the source ID and receive a second message from the server of thesurgical device manufacturer. The first message comprises the encryptedidentifier, and is encrypted using a public key associated with thesurgical device manufacturer. The second message is encrypted using apublic key associated with the surgical hub. The encrypted secondmessage comprises a shared secret associated with the encryptedidentifier of the surgical device. The instructions executable by theprocessor also: decrypt the encrypted second message using a private keyassociated with the public key used to encrypt the second message toreveal the shared secret associated with the encrypted identifier of thesurgical device; and decrypt the encrypted identifier of the surgicaldevice using the shared secret to reveal the identifier to authenticatethe surgical device and its manufacturer.

FIGURES

The features of various aspects are set forth with particularity in theappended claims. The various aspects, however, both as to organizationand methods of operation, together with further objects and advantagesthereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings asfollows.

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 2 is a surgical system being used to perform a surgical procedurein an operating room, in accordance with at least one aspect of thepresent disclosure.

FIG. 3 is a surgical hub paired with a visualization system, a roboticsystem, and an intelligent instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 4 is a partial perspective view of a surgical hub enclosure, and ofa combo generator module slidably receivable in a drawer of the surgicalhub enclosure, in accordance with at least one aspect of the presentdisclosure.

FIG. 5 is a perspective view of a combo generator module with bipolar,ultrasonic, and monopolar contacts and a smoke evacuation component, inaccordance with at least one aspect of the present disclosure.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing configured to receivea plurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 7 illustrates a vertical modular housing configured to receive aplurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 8 illustrates a surgical data network comprising a modularcommunication hub configured to connect modular devices located in oneor more operating theaters of a healthcare facility, or any room in ahealthcare facility specially equipped for surgical operations, to thecloud, in accordance with at least one aspect of the present disclosure.

FIG. 9 illustrates a computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 10 illustrates a surgical hub comprising a plurality of modulescoupled to the modular control tower, in accordance with at least oneaspect of the present disclosure.

FIG. 11 illustrates one aspect of a Universal Serial Bus (USB) networkhub device, in accordance with at least one aspect of the presentdisclosure.

FIG. 12 illustrates a logic diagram of a control system of a surgicalinstrument or tool, in accordance with at least one aspect of thepresent disclosure.

FIG. 13 illustrates a control circuit configured to control aspects ofthe surgical instrument or tool, in accordance with at least one aspectof the present disclosure.

FIG. 14 illustrates a combinational logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 15 illustrates a sequential logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 16 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions, inaccordance with at least one aspect of the present disclosure.

FIG. 17 is a schematic diagram of a robotic surgical instrumentconfigured to operate a surgical tool described herein, in accordancewith at least one aspect of the present disclosure.

FIG. 18 illustrates a block diagram of a surgical instrument programmedto control the distal translation of a displacement member, inaccordance with at least one aspect of the present disclosure.

FIG. 19 is a schematic diagram of a surgical instrument configured tocontrol various functions, in accordance with at least one aspect of thepresent disclosure.

FIG. 20 is a simplified block diagram of a generator configured toprovide inductorless tuning, among other benefits, in accordance with atleast one aspect of the present disclosure.

FIG. 21 illustrates an example of a generator, which is one form of thegenerator of FIG. 20, in accordance with at least one aspect of thepresent disclosure.

FIG. 22 illustrates a combination generator, in accordance with at leastone aspect of the present disclosure.

FIG. 23 illustrates a method of capturing data from a combinationgenerator and communicating the captured generator data to a cloud-basedsystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 24 illustrates a data packet of combination generator data, inaccordance with at least one aspect of the present disclosure.

FIG. 25 illustrates an encryption algorithm, in accordance with at leastone aspect of the present disclosure.

FIG. 26 illustrates another encryption algorithm, in accordance with atleast one aspect of the present disclosure.

FIG. 27 illustrates yet another encryption algorithm, in accordance withat least one aspect of the present disclosure.

FIG. 28 illustrates a high-level representation of a datagram, inaccordance with at least one aspect of the present disclosure.

FIG. 29 illustrates a more detailed representation of the datagram ofFIG. 28, in accordance with at least one aspect of the presentdisclosure.

FIG. 30 illustrates another representation of the datagram of FIG. 28,in accordance with at least one aspect of the present disclosure.

FIG. 31 illustrates a method of identifying surgical data associatedwith a failure event and communicating the identified surgical data to acloud-based system on a prioritized basis, in accordance with at leastone aspect of the present disclosure.

FIG. 32 illustrates yet another representation of the datagram of FIG.28, in accordance with at least one aspect of the present disclosure.

FIG. 33 illustrates a partial artificial timeline of a surgicalprocedure performed in an operating room via a surgical system, inaccordance with at least one aspect of the present disclosure.

FIG. 34 illustrates ultrasonic pinging of an operating room wall todetermine a distance between a surgical hub and the operating room wall,in accordance with at least one aspect of the present disclosure.

FIG. 35 is a logic flow diagram of a process depicting a control programor a logic configuration for surgical hub pairing with surgical devicesof a surgical system that are located within the bounds of an operatingroom, in accordance with at least one aspect of the present disclosure.

FIG. 36 is a logic flow diagram of a process depicting a control programor a logic configuration for selectively forming and severingconnections between devices of a surgical system, in accordance with atleast one aspect of the present disclosure.

FIG. 37 is a logic flow diagram of a process depicting a control programor a logic configuration for selectively reevaluating the bounds of anoperating room after detecting a new device, in accordance with at leastone aspect of the present disclosure.

FIG. 38 is a logic flow diagram of a process depicting a control programor a logic configuration for selectively reevaluating the bounds of anoperating room after disconnection of a paired device, in accordancewith at least one aspect of the present disclosure.

FIG. 39 is a logic flow diagram of a process depicting a control programor a logic configuration for reevaluating the bounds of an operatingroom by a surgical hub after detecting a change in the position of thesurgical hub, in accordance with at least one aspect of the presentdisclosure.

FIG. 40 is a logic flow diagram of a process depicting a control programor a logic configuration for selectively forming connections betweendevices of a surgical system, in accordance with at least one aspect ofthe present disclosure.

FIG. 41 is a logic flow diagram of a process depicting a control programor a logic configuration for selectively forming and severingconnections between devices of a surgical system, in accordance with atleast one aspect of the present disclosure.

FIG. 42 illustrates a surgical hub pairing a first device and a seconddevice of a surgical system in an operating room, in accordance with atleast one aspect of the present disclosure.

FIG. 43 illustrates a surgical hub unpairing a first device and a seconddevice of a surgical system in an operating room, and pairing the firstdevice with a third device in the operating room, in accordance with atleast one aspect of the present disclosure.

FIG. 44 is a logic flow diagram of a process depicting a control programor a logic configuration for forming an severing connections betweendevices of a surgical system in an operating room during a surgicalprocedure based on progression of the steps of the surgical procedure,in accordance with at least one aspect of the present disclosure.

FIG. 45 is a logic flow diagram of a process depicting a control programor a logic configuration for overlaying information derived from one ormore still frames of a livestream of a remote surgical site onto thelivestream, in accordance with at least one aspect of the presentdisclosure.

FIG. 46 is a logic flow diagram of a process depicting a control programor a logic configuration for differentiating among surgical steps of asurgical procedure, in accordance with at least one aspect of thepresent disclosure.

FIG. 47 is a logic flow diagram of a process 3230 depicting a controlprogram or a logic configuration for differentiating among surgicalsteps of a surgical procedure, in accordance with at least one aspect ofthe present disclosure.

FIG. 48 is a logic flow diagram of a process 3240 depicting a controlprogram or a logic configuration for identifying a staple cartridge frominformation derived from one or more still frames of staples deployedfrom the staple cartridge into tissue, in accordance with at least oneaspect of the present disclosure.

FIG. 49 is a partial view of a surgical system in an operating room, thesurgical system including a surgical hub that has an imaging module incommunication with an imaging device at a remote surgical site, inaccordance with at least one aspect of the present disclosure.

FIG. 50 illustrates a partial view of stapled tissue that received afirst staple firing and a second staple firing arranged end-to-end, inaccordance with at least one aspect of the present disclosure.

FIG. 51 illustrates three rows of staples deployed on one side of atissue stapled and cut by a surgical stapler, in accordance with atleast one aspect of the present disclosure.

FIG. 52 illustrates a non-anodized staple and an anodized staple, inaccordance with at least one aspect of the present disclosure.

FIG. 53 is a logic flow diagram of a process depicting a control programor a logic configuration for coordinating a control arrangement betweensurgical hubs, in accordance with at least one aspect of the presentdisclosure.

FIG. 54 illustrates an interaction between two surgical hubs in anoperating room, in accordance with at least one aspect of the presentdisclosure.

FIG. 55 is a logic flow diagram of a process depicting a control programor a logic configuration for coordinating a control arrangement betweensurgical hubs, in accordance with at least one aspect of the presentdisclosure.

FIG. 56 illustrates an interaction between two surgical hubs indifferent operating rooms (“OR1” and “OR3”), in accordance with at leastone aspect of the present disclosure.

FIG. 57 illustrates a secondary display in an operating room (“OR3”)showing a surgical site in a colorectal procedure, in accordance with atleast one aspect of the present disclosure.

FIG. 58 illustrates a personal interface or tablet in OR1 displaying thesurgical site of OR3, in accordance with at least one aspect of thepresent disclosure.

FIG. 59 illustrates an expanded view of the surgical site of OR3displayed on a primary display of OR1, in accordance with at least oneaspect of the present disclosure.

FIG. 60 illustrates a personal interface or tablet displaying a layoutof OR1 that shows available displays, in accordance with at least oneaspect of the present disclosure.

FIG. 61 illustrates a recommendation of a transection location of asurgical site of OR3 made by a surgical operator in OR1 via a personalinterface or tablet in OR1, in accordance with at least one aspect ofthe present disclosure.

FIG. 62 illustrates a timeline depicting situational awareness of asurgical hub, in accordance with at least one aspect of the presentdisclosure.

DESCRIPTION

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Mar. 28, 2018, each of which is hereinincorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/649,302, titled        INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION        CAPABILITIES;    -   U.S. Provisional Patent Application Ser. No. 62/649,294, titled        DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. Provisional Patent Application Ser. No. 62/649,300, titled        SURGICAL HUB SITUATIONAL AWARENESS;    -   U.S. Provisional Patent Application Ser. No. 62/649,309, titled        SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING        THEATER;    -   U.S. Provisional Patent Application Ser. No. 62/649,310, titled        COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,291, titled        USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE        PROPERTIES OF BACK SCATTERED LIGHT;    -   U.S. Provisional Patent Application Ser. No. 62/649,296, titled        ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,333, titled        CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND        RECOMMENDATIONS TO A USER;    -   U.S. Provisional Patent Application Ser. No. 62/649,327, titled        CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION        TRENDS AND REACTIVE MEASURES;    -   U.S. Provisional Patent Application Ser. No. 62/649,315, titled        DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;    -   U.S. Provisional Patent Application Ser. No. 62/649,313, titled        CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,320, titled        DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,307, titled        AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS; and    -   U.S. Provisional Patent Application Ser. No. 62/649,323, titled        SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, each of which is hereinincorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,641, titled INTERACTIVE        SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES, now        U.S. Pat. No. 10,944,728;    -   U.S. patent application Ser. No. 15/940,656, titled SURGICAL HUB        COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM        DEVICES, now U.S. Pat. No. 2019/0201141;    -   U.S. patent application Ser. No. 15/940,666, titled SPATIAL        AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS, now U.S. Patent        Application Publication No. 2019/0206551;    -   U.S. patent application Ser. No. 15/940,670, titled COOPERATIVE        UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY        INTELLIGENT SURGICAL HUBS, now U.S. Patent Application        Publication No. 2019/0201116;    -   U.S. patent application Ser. No. 15/940,677, titled SURGICAL HUB        CONTROL ARRANGEMENTS, now U.S. Pat. No. 10,987,178;    -   U.S. patent application Ser. No. 15/940,632, titled DATA        STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD, now U.S. Patent Application Publication No.        2019/0205566;    -   U.S. patent application Ser. No. 15/940,640, titled        COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND        STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED        ANALYTICS SYSTEMS, now U.S. Patent Application Publication No.        2019/0200863;    -   U.S. patent application Ser. No. 15/940,645, titled SELF        DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT, now        U.S. Pat. No. 10,892,899;    -   U.S. patent application Ser. No. 15/940,649, titled DATA PAIRING        TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME, now        U.S. Patent Application Publication No. 2019/0205567;    -   U.S. patent application Ser. No. 15/940,654, titled SURGICAL HUB        SITUATIONAL AWARENESS, now U.S. Patent Application Publication        No. 2019/0201140;    -   U.S. patent application Ser. No. 15/940,663, titled SURGICAL        SYSTEM DISTRIBUTED PROCESSING, now U.S. Patent Application        Publication No. 2019/0201033;    -   U.S. patent application Ser. No. 15/940,648, titled AGGREGATION        AND REPORTING OF SURGICAL HUB DATA, now U.S. Patent Application        Publication No. 2019/0201115;    -   U.S. patent application Ser. No. 15/940,671, titled SURGICAL HUB        SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER, now        U.S. Patent Application Publication No. 2019/0201104;    -   U.S. patent application Ser. No. 15/940,686, titled DISPLAY OF        ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE, now        U.S. Patent Application Publication No. 2019/0201105;    -   U.S. patent application Ser. No. 15/940,700, titled STERILE        FIELD INTERACTIVE CONTROL DISPLAYS, now U.S. Patent Application        Publication No. 2019/0205001;    -   U.S. patent application Ser. No. 15/940,629, titled COMPUTER        IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS, now U.S. Patent        Application Publication No. 2019/0201112;    -   U.S. patent application Ser. No. 15/940,704, titled USE OF LASER        LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF        BACK SCATTERED LIGHT, now U.S. Patent Application Publication        No. 2019/0206050;    -   U.S. patent application Ser. No. 15/940,722, titled        CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF        MONO-CHROMATIC LIGHT REFRACTIVITY, now U.S. Patent Application        Publication No. 2019/0200905; and    -   U.S. patent application Ser. No. 15/940,742, titled DUAL CMOS        ARRAY IMAGING, now U.S. Patent Application Publication No.        2019/0200906.

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, each of which is hereinincorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,636, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES, now U.S. Patent        Application Publication No. 2019/0206003;    -   U.S. patent application Ser. No. 15/940,653, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES, now U.S. Patent        Application Publication No. 2019/0201114;    -   U.S. patent application Ser. No. 15/940,660, titled CLOUD-BASED        MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A        USER, now U.S. Patent Application Publication No. 2019/0206555;    -   U.S. patent application Ser. No. 15/940,679, titled CLOUD-BASED        MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE        RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET, now U.S. Pat.        No. 10,932,872;    -   U.S. patent application Ser. No. 15/940,694, titled CLOUD-BASED        MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED        INDIVIDUALIZATION OF INSTRUMENT FUNCTION, now U.S. Pat. No.        10,966,791;    -   U.S. patent application Ser. No. 15/940,634, titled CLOUD-BASED        MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND        REACTIVE MEASURES, now U.S. Patent Application Publication No.        2019/0201138;    -   U.S. patent application Ser. No. 15/940,706, titled DATA        HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK, now        U.S. Patent Application Publication No. 2019/0206561; and    -   U.S. patent application Ser. No. 15/940,675, titled CLOUD        INTERFACE FOR COUPLED SURGICAL DEVICES, now U.S. Pat. No.        10,849,697.

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, each of which is hereinincorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,627, titled DRIVE        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S.        Pat. No. 11,013,563;    -   U.S. patent application Ser. No. 15/940,637, titled        COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS, now U.S. Patent Application Publication No.        2019/0201139;    -   U.S. patent application Ser. No. 15/940,642, titled CONTROLS FOR        ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S. Patent Application        Publication No. 2019/0201113;    -   U.S. patent application Ser. No. 15/940,676, titled AUTOMATIC        TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S.        Patent Application Publication No. 2019/0201142;    -   U.S. patent application Ser. No. 15/940,680, titled CONTROLLERS        FOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S. Patent        Application Publication No. 2019/0201135;    -   U.S. patent application Ser. No. 15/940,683, titled COOPERATIVE        SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S.        Patent Application Publication No. 2019/0201145;    -   U.S. patent application Ser. No. 15/940,690, titled DISPLAY        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S.        Patent Application Publication No. 2019/0201118; and    -   U.S. patent application Ser. No. 15/940,711, titled SENSING        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S.        Patent Application Publication No. 2019/0201120.

Before explaining various aspects of surgical devices and generators indetail, it should be noted that the illustrative examples are notlimited in application or use to the details of construction andarrangement of parts illustrated in the accompanying drawings anddescription. The illustrative examples may be implemented orincorporated in other aspects, variations and modifications, and may bepracticed or carried out in various ways. Further, unless otherwiseindicated, the terms and expressions employed herein have been chosenfor the purpose of describing the illustrative examples for theconvenience of the reader and are not for the purpose of limitationthereof. Also, it will be appreciated that one or more of thefollowing-described aspects, expressions of aspects, and/or examples,can be combined with any one or more of the other following-describedaspects, expressions of aspects and/or examples.

Referring to FIG. 1, a computer-implemented interactive surgical system100 includes one or more surgical systems 102 and a cloud-based system(e.g., the cloud 104 that may include a remote server 113 coupled to astorage device 105). Each surgical system 102 includes at least onesurgical hub 106 in communication with the cloud 104 that may include aremote server 113. In one example, as illustrated in FIG. 1, thesurgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or the hub 106. Insome aspects, a surgical system 102 may include an M number of hubs 106,an N number of visualization systems 108, an O number of robotic systems110, and a P number of handheld intelligent surgical instruments 112,where M, N, O, and P are integers greater than or equal to one.

FIG. 3 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. A robotic system 110 is usedin the surgical procedure as a part of the surgical system 102. Therobotic system 110 includes a surgeon's console 118, a patient side cart120 (surgical robot), and a surgical robotic hub 122. The patient sidecart 120 can manipulate at least one removably coupled surgical tool 117through a minimally invasive incision in the body of the patient whilethe surgeon views the surgical site through the surgeon's console 118.An image of the surgical site can be obtained by a medical imagingdevice 124, which can be manipulated by the patient side cart 120 toorient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,339,titled ROBOT ASSISTED SURGICAL PLATFORM, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,340,titled CLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 includes at least one imagesensor and one or more optical components. Suitable image sensorsinclude, but are not limited to, Charge-Coupled Device (CCD) sensors andComplementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (i.e., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

In one aspect, the imaging device employs multi-spectrum monitoring todiscriminate topography and underlying structures. A multi-spectralimage is one that captures image data within specific wavelength rangesacross the electromagnetic spectrum. The wavelengths may be separated byfilters or by the use of instruments that are sensitive to particularwavelengths, including light from frequencies beyond the visible lightrange, e.g., IR and ultraviolet. Spectral imaging can allow extractionof additional information the human eye fails to capture with itsreceptors for red, green, and blue. The use of multi-spectral imaging isdescribed in greater detail under the heading “Advanced ImagingAcquisition Module” in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety. Multi-spectrum monitoring can be a useful tool in relocating asurgical field after a surgical task is completed to perform one or moreof the previously described tests on the treated tissue.

It is axiomatic that strict sterilization of the operating room andsurgical equipment is required during any surgery. The strict hygieneand sterilization conditions required in a “surgical theater,” i.e., anoperating or treatment room, necessitate the highest possible sterilityof all medical devices and equipment. Part of that sterilization processis the need to sterilize anything that comes in contact with the patientor penetrates the sterile field, including the imaging device 124 andits attachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

In various aspects, the visualization system 108 includes one or moreimaging sensors, one or more image-processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2. In one aspect,the visualization system 108 includes an interface for HL7, PACS, andEMR. Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S.Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2, a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 includes a first non-sterile display107 and a second non-sterile display 109, which face away from eachother. The visualization system 108, guided by the hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, the hub 106 may cause the visualization system 108 to display asnapshot of a surgical site, as recorded by an imaging device 124, on anon-sterile display 107 or 109, while maintaining a live feed of thesurgical site on the primary display 119. The snapshot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, the hub 106 is also configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snapshotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary display 119 by the hub 106.

Referring to FIG. 2, a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. The hub 106 isalso configured to coordinate information flow to a display of thesurgical instrument 112. For example, in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, the disclosure of which is herein incorporated byreference in its entirety. A diagnostic input or feedback entered by anon-sterile operator at the visualization tower 111 can be routed by thehub 106 to the surgical instrument display 115 within the sterile field,where it can be viewed by the operator of the surgical instrument 112.Example surgical instruments that are suitable for use with the surgicalsystem 102 are described under the heading “Surgical InstrumentHardware” and in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety, for example.

Referring now to FIG. 3, a hub 106 is depicted in communication with avisualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. The hub 106 includes a hub display135, an imaging module 138, a generator module 140, a communicationmodule 130, a processor module 132, and a storage array 134. In certainaspects, as illustrated in FIG. 3, the hub 106 further includes a smokeevacuation module 126 and/or a suction/irrigation module 128.

During a surgical procedure, energy application to tissue, for sealingand/or cutting, is generally associated with smoke evacuation, suctionof excess fluid, and/or irrigation of the tissue. Fluid, power, and/ordata lines from different sources are often entangled during thesurgical procedure. Valuable time can be lost addressing this issueduring a surgical procedure. Detangling the lines may necessitatedisconnecting the lines from their respective modules, which may requireresetting the modules. The hub modular enclosure 136 offers a unifiedenvironment for managing the power, data, and fluid lines, which reducesthe frequency of entanglement between such lines.

Aspects of the present disclosure present a surgical hub for use in asurgical procedure that involves energy application to tissue at asurgical site. The surgical hub includes a hub enclosure and a combogenerator module slidably receivable in a docking station of the hubenclosure. The docking station includes data and power contacts. Thecombo generator module includes two or more of an ultrasonic energygenerator component, a bipolar RF energy generator component, and amonopolar RF energy generator component that are housed in a singleunit. In one aspect, the combo generator module also includes a smokeevacuation component, at least one energy delivery cable for connectingthe combo generator module to a surgical instrument, at least one smokeevacuation component configured to evacuate smoke, fluid, and/orparticulates generated by the application of therapeutic energy to thetissue, and a fluid line extending from the remote surgical site to thesmoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluidline extends from the remote surgical site to a suction and irrigationmodule slidably received in the hub enclosure. In one aspect, the hubenclosure comprises a fluid interface.

Certain surgical procedures may require the application of more than oneenergy type to the tissue. One energy type may be more beneficial forcutting the tissue, while another different energy type may be morebeneficial for sealing the tissue. For example, a bipolar generator canbe used to seal the tissue while an ultrasonic generator can be used tocut the sealed tissue. Aspects of the present disclosure present asolution where a hub modular enclosure 136 is configured to accommodatedifferent generators, and facilitate an interactive communicationtherebetween. One of the advantages of the hub modular enclosure 136 isenabling the quick removal and/or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosurefor use in a surgical procedure that involves energy application totissue. The modular surgical enclosure includes a first energy-generatormodule, configured to generate a first energy for application to thetissue, and a first docking station comprising a first docking port thatincludes first data and power contacts, wherein the firstenergy-generator module is slidably movable into an electricalengagement with the power and data contacts and wherein the firstenergy-generator module is slidably movable out of the electricalengagement with the first power and data contacts,

Further to the above, the modular surgical enclosure also includes asecond energy-generator module configured to generate a second energy,different than the first energy, for application to the tissue, and asecond docking station comprising a second docking port that includessecond data and power contacts, wherein the second energy-generatormodule is slidably movable into an electrical engagement with the powerand data contacts, and wherein the second energy-generator module isslidably movable out of the electrical engagement with the second powerand data contacts.

In addition, the modular surgical enclosure also includes acommunication bus between the first docking port and the second dockingport, configured to facilitate communication between the firstenergy-generator module and the second energy-generator module.

Referring to FIGS. 3-7, aspects of the present disclosure are presentedfor a hub modular enclosure 136 that allows the modular integration of agenerator module 140, a smoke evacuation module 126, and asuction/irrigation module 128. The hub modular enclosure 136 furtherfacilitates interactive communication between the modules 140, 126, 128.As illustrated in FIG. 5, the generator module 140 can be a generatormodule with integrated monopolar, bipolar, and ultrasonic componentssupported in a single housing unit 139 slidably insertable into the hubmodular enclosure 136. As illustrated in FIG. 5, the generator module140 can be configured to connect to a monopolar device 146, a bipolardevice 147, and an ultrasonic device 148. Alternatively, the generatormodule 140 may comprise a series of monopolar, bipolar, and/orultrasonic generator modules that interact through the hub modularenclosure 136. The hub modular enclosure 136 can be configured tofacilitate the insertion of multiple generators and interactivecommunication between the generators docked into the hub modularenclosure 136 so that the generators would act as a single generator.

In one aspect, the hub modular enclosure 136 comprises a modular powerand communication backplane 149 with external and wireless communicationheaders to enable the removable attachment of the modules 140, 126, 128and interactive communication therebetween.

In one aspect, the hub modular enclosure 136 includes docking stations,or drawers, 151, herein also referred to as drawers, which areconfigured to slidably receive the modules 140, 126, 128. FIG. 4illustrates a partial perspective view of a surgical hub enclosure 136,and a combo generator module 145 slidably receivable in a dockingstation 151 of the surgical hub enclosure 136. A docking port 152 withpower and data contacts on a rear side of the combo generator module 145is configured to engage a corresponding docking port 150 with power anddata contacts of a corresponding docking station 151 of the hub modularenclosure 136 as the combo generator module 145 is slid into positionwithin the corresponding docking station 151 of the hub module enclosure136. In one aspect, the combo generator module 145 includes a bipolar,ultrasonic, and monopolar module and a smoke evacuation moduleintegrated together into a single housing unit 139, as illustrated inFIG. 5.

In various aspects, the smoke evacuation module 126 includes a fluidline 154 that conveys captured/collected smoke and/or fluid away from asurgical site and to, for example, the smoke evacuation module 126.Vacuum suction originating from the smoke evacuation module 126 can drawthe smoke into an opening of a utility conduit at the surgical site. Theutility conduit, coupled to the fluid line, can be in the form of aflexible tube terminating at the smoke evacuation module 126. Theutility conduit and the fluid line define a fluid path extending towardthe smoke evacuation module 126 that is received in the hub enclosure136.

In various aspects, the suction/irrigation module 128 is coupled to asurgical tool comprising an aspiration fluid line and a suction fluidline. In one example, the aspiration and suction fluid lines are in theform of flexible tubes extending from the surgical site toward thesuction/irrigation module 128. One or more drive systems can beconfigured to cause irrigation and aspiration of fluids to and from thesurgical site.

In one aspect, the surgical tool includes a shaft having an end effectorat a distal end thereof and at least one energy treatment associatedwith the end effector, an aspiration tube, and an irrigation tube. Theaspiration tube can have an inlet port at a distal end thereof and theaspiration tube extends through the shaft. Similarly, an irrigation tubecan extend through the shaft and can have an inlet port in proximity tothe energy deliver implement. The energy deliver implement is configuredto deliver ultrasonic and/or RF energy to the surgical site and iscoupled to the generator module 140 by a cable extending initiallythrough the shaft.

The irrigation tube can be in fluid communication with a fluid source,and the aspiration tube can be in fluid communication with a vacuumsource. The fluid source and/or the vacuum source can be housed in thesuction/irrigation module 128. In one example, the fluid source and/orthe vacuum source can be housed in the hub enclosure 136 separately fromthe suction/irrigation module 128. In such example, a fluid interfacecan be configured to connect the suction/irrigation module 128 to thefluid source and/or the vacuum source.

In one aspect, the modules 140, 126, 128 and/or their correspondingdocking stations on the hub modular enclosure 136 may include alignmentfeatures that are configured to align the docking ports of the modulesinto engagement with their counterparts in the docking stations of thehub modular enclosure 136. For example, as illustrated in FIG. 4, thecombo generator module 145 includes side brackets 155 that areconfigured to slidably engage with corresponding brackets 156 of thecorresponding docking station 151 of the hub modular enclosure 136. Thebrackets cooperate to guide the docking port contacts of the combogenerator module 145 into an electrical engagement with the docking portcontacts of the hub modular enclosure 136.

In some aspects, the drawers 151 of the hub modular enclosure 136 arethe same, or substantially the same size, and the modules are adjustedin size to be received in the drawers 151. For example, the sidebrackets 155 and/or 156 can be larger or smaller depending on the sizeof the module. In other aspects, the drawers 151 are different in sizeand are each designed to accommodate a particular module.

Furthermore, the contacts of a particular module can be keyed forengagement with the contacts of a particular drawer to avoid inserting amodule into a drawer with mismatching contacts.

As illustrated in FIG. 4, the docking port 150 of one drawer 151 can becoupled to the docking port 150 of another drawer 151 through acommunications link 157 to facilitate an interactive communicationbetween the modules housed in the hub modular enclosure 136. The dockingports 150 of the hub modular enclosure 136 may alternatively, oradditionally, facilitate a wireless interactive communication betweenthe modules housed in the hub modular enclosure 136. Any suitablewireless communication can be employed, such as for example AirTitan-Bluetooth.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing 160 configured toreceive a plurality of modules of a surgical hub 206. The lateralmodular housing 160 is configured to laterally receive and interconnectthe modules 161. The modules 161 are slidably inserted into dockingstations 162 of lateral modular housing 160, which includes a backplanefor interconnecting the modules 161. As illustrated in FIG. 6, themodules 161 are arranged laterally in the lateral modular housing 160.Alternatively, the modules 161 may be arranged vertically in a lateralmodular housing.

FIG. 7 illustrates a vertical modular housing 164 configured to receivea plurality of modules 165 of the surgical hub 106. The modules 165 areslidably inserted into docking stations, or drawers, 167 of verticalmodular housing 164, which includes a backplane for interconnecting themodules 165. Although the drawers 167 of the vertical modular housing164 are arranged vertically, in certain instances, a vertical modularhousing 164 may include drawers that are arranged laterally.Furthermore, the modules 165 may interact with one another through thedocking ports of the vertical modular housing 164. In the example ofFIG. 7, a display 177 is provided for displaying data relevant to theoperation of the modules 165. In addition, the vertical modular housing164 includes a master module 178 housing a plurality of sub-modules thatare slidably received in the master module 178.

In various aspects, the imaging module 138 comprises an integrated videoprocessor and a modular light source and is adapted for use with variousimaging devices. In one aspect, the imaging device is comprised of amodular housing that can be assembled with a light source module and acamera module. The housing can be a disposable housing. In at least oneexample, the disposable housing is removably coupled to a reusablecontroller, a light source module, and a camera module. The light sourcemodule and/or the camera module can be selectively chosen depending onthe type of surgical procedure. In one aspect, the camera modulecomprises a CCD sensor. In another aspect, the camera module comprises aCMOS sensor. In another aspect, the camera module is configured forscanned beam imaging. Likewise, the light source module can beconfigured to deliver a white light or a different light, depending onthe surgical procedure.

During a surgical procedure, removing a surgical device from thesurgical field and replacing it with another surgical device thatincludes a different camera or a different light source can beinefficient. Temporarily losing sight of the surgical field may lead toundesirable consequences. The module imaging device of the presentdisclosure is configured to permit the replacement of a light sourcemodule or a camera module midstream during a surgical procedure, withouthaving to remove the imaging device from the surgical field.

In one aspect, the imaging device comprises a tubular housing thatincludes a plurality of channels. A first channel is configured toslidably receive the camera module, which can be configured for asnap-fit engagement with the first channel. A second channel isconfigured to slidably receive the light source module, which can beconfigured for a snap-fit engagement with the second channel. In anotherexample, the camera module and/or the light source module can be rotatedinto a final position within their respective channels. A threadedengagement can be employed in lieu of the snap-fit engagement.

In various examples, multiple imaging devices are placed at differentpositions in the surgical field to provide multiple views. The imagingmodule 138 can be configured to switch between the imaging devices toprovide an optimal view. In various aspects, the imaging module 138 canbe configured to integrate the images from the different imaging device.

Various image processors and imaging devices suitable for use with thepresent disclosure are described in U.S. Pat. No. 7,995,045, titledCOMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, which issued on Aug. 9,2011, which is herein incorporated by reference in its entirety. Inaddition, U.S. Pat. No. 7,982,776, titled SBI MOTION ARTIFACT REMOVALAPPARATUS AND METHOD, which issued on Jul. 19, 2011, which is hereinincorporated by reference in its entirety, describes various systems forremoving motion artifacts from image data. Such systems can beintegrated with the imaging module 138. Furthermore, U.S. PatentApplication Publication No. 2011/0306840, titled CONTROLLABLE MAGNETICSOURCE TO FIXTURE INTRACORPOREAL APPARATUS, which published on Dec. 15,2011, and U.S. Patent Application Publication No. 2014/0243597, titledSYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, whichpublished on Aug. 28, 2014, each of which is herein incorporated byreference in its entirety.

FIG. 8 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to acloud-based system (e.g., the cloud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network serves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switch(es), and network router(s) connectingthe devices 1 a-1 n/2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/2 a-2 m coupled to the network hub or network switch maycollect data in real time and transfer the data to cloud computers fordata processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services—such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a fixed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovider. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. The hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices 1 a-1 n/2 a-2 m, the surgical data network providesimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue sealing and cutting procedure. At least some ofthe devices 1 a-1 n/2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This includes localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/2 a-2 m may be employedto identify anatomical structures of the body using a variety of sensorsintegrated with imaging devices and techniques such as overlaying imagescaptured by multiple imaging devices. The data gathered by the devices 1a-1 n/2 a-2 m, including image data, may be transferred to the cloud 204or the local computer system 210 or both for data processing andmanipulation including image processing and manipulation. The data maybe analyzed to improve surgical procedure outcomes by determining iffurther treatment, such as the application of endoscopic intervention,emerging technologies, a targeted radiation, targeted intervention, andprecise robotics to tissue-specific sites and conditions, may bepursued. Such data analysis may further employ outcome analyticsprocessing, and using standardized approaches may provide beneficialfeedback to either confirm surgical treatments and the behavior of thesurgeon or suggest modifications to surgical treatments and the behaviorof the surgeon.

In one implementation, the operating theater devices 1 a-1 n may beconnected to the modular communication hub 203 over a wired channel or awireless channel depending on the configuration of the devices 1 a-1 nto a network hub. The network hub 207 may be implemented, in one aspect,as a local network broadcast device that works on the physical layer ofthe Open System Interconnection (OSI) model. The network hub providesconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 collects data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 does not store any media access control/Internet Protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207has no routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 9) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

In another implementation, the operating theater devices 2 a-2 m may beconnected to a network switch 209 over a wired channel or a wirelesschannel. The network switch 209 works in the data link layer of the OSImodel. The network switch 209 is a multicast device for connecting thedevices 2 a-2 m located in the same operating theater to the network.The network switch 209 sends data in the form of frames to the networkrouter 211 and works in full duplex mode. Multiple devices 2 a-2 m cansend data at the same time through the network switch 209. The networkswitch 209 stores and uses MAC addresses of the devices 2 a-2 m totransfer data.

The network hub 207 and/or the network switch 209 are coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network layer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 211 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 sends data in the form of packets to the cloud 204 and worksin full duplex mode. Multiple devices can send data at the same time.The network router 211 uses IP addresses to transfer data.

In one example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In other examples, the operating theater devices 1 a-1 n/2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). In other aspects, the operating theater devices 1 a-1 n/2 a-2 mmay communicate to the modular communication hub 203 via a number ofwireless or wired communication standards or protocols, including butnot limited to W-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family),IEEE 802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+,HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivativesthereof, as well as any other wireless and wired protocols that aredesignated as 3G, 4G, 5G, and beyond. The computing module may include aplurality of communication modules. For instance, a first communicationmodule may be dedicated to shorter-range wireless communications such asWi-Fi and Bluetooth, and a second communication module may be dedicatedto longer-range wireless communications such as GPS, EDGE, GPRS, CDMA,WiMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/2 a-2 m and handlesa data type known as frames. Frames carry the data generated by thedevices 1 a-1 n/2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 is generally easy toinstall, configure, and maintain, making it a good option for networkingthe operating theater devices 1 a-1 n/2 a-2 m.

FIG. 9 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote server 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown in FIG. 10, the modularcontrol tower 236 comprises a modular communication hub 203 coupled to acomputer system 210. As illustrated in the example of FIG. 9, themodular control tower 236 is coupled to an imaging module 238 that iscoupled to an endoscope 239, a generator module 240 that is coupled toan energy device 241, a smoke evacuator module 226, a suction/irrigationmodule 228, a communication module 230, a processor module 232, astorage array 234, a smart device/instrument 235 optionally coupled to adisplay 237, and a non-contact sensor module 242. The operating theaterdevices are coupled to cloud computing resources and data storage viathe modular control tower 236. A robot hub 222 also may be connected tothe modular control tower 236 and to the cloud computing resources. Thedevices/instruments 235, visualization systems 208, among others, may becoupled to the modular control tower 236 via wired or wirelesscommunication standards or protocols, as described herein. The modularcontrol tower 236 may be coupled to a hub display 215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

FIG. 10 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control tower 236comprises a modular communication hub 203, e.g., a network connectivitydevice, and a computer system 210 to provide local processing,visualization, and imaging, for example. As shown in FIG. 10, themodular communication hub 203 may be connected in a tiered configurationto expand the number of modules (e.g., devices) that may be connected tothe modular communication hub 203 and transfer data associated with themodules to the computer system 210, cloud computing resources, or both.As shown in FIG. 10, each of the network hubs/switches in the modularcommunication hub 203 includes three downstream ports and one upstreamport. The upstream network hub/switch is connected to a processor toprovide a communication connection to the cloud computing resources anda local display 217. Communication to the cloud 204 may be made eitherthrough a wired or a wireless communication channel.

The surgical hub 206 employs a non-contact sensor module 242 to measurethe dimensions of the operating theater and generate a map of thesurgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module scansthe operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is herein incorporated by reference in itsentirety, in which the sensor module is configured to determine the sizeof the operating theater and to adjust Bluetooth-pairing distancelimits. A laser-based non-contact sensor module scans the operatingtheater by transmitting laser light pulses, receiving laser light pulsesthat bounce off the perimeter walls of the operating theater, andcomparing the phase of the transmitted pulse to the received pulse todetermine the size of the operating theater and to adjust Bluetoothpairing distance limits, for example.

The computer system 210 comprises a processor 244 and a networkinterface 245. The processor 244 is coupled to a communication module247, storage 248, memory 249, non-volatile memory 250, and input/outputinterface 251 via a system bus. The system bus can be any of severaltypes of bus structure(s) including the memory bus or memory controller,a peripheral bus or external bus, and/or a local bus using any varietyof available bus architectures including, but not limited to, 9-bit bus,Industrial Standard Architecture (ISA), Micro-Channel Architecture(MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESALocal Bus (VLB), Peripheral Component Interconnect (PCI), USB, AdvancedGraphics Port (AGP), Personal Computer Memory Card InternationalAssociation bus (PCMCIA), Small Computer Systems Interface (SCSI), orany other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory includes volatile memory and non-volatile memory. Thebasic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during start-up, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and directRambus RAM (DRRAM).

The computer system 210 also includes removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage includes, but is not limited to, devices likea magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zipdrive, LS-60 drive, flash memory card, or memory stick. In addition, thedisk storage can include storage media separately or in combination withother storage media including, but not limited to, an optical disc drivesuch as a compact disc ROM device (CD-ROM), compact disc recordabledrive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or adigital versatile disc ROM drive (DVD-ROM). To facilitate the connectionof the disk storage devices to the system bus, a removable ornon-removable interface may be employed.

It is to be appreciated that the computer system 210 includes softwarethat acts as an intermediary between users and the basic computerresources described in a suitable operating environment. Such softwareincludes an operating system. The operating system, which can be storedon the disk storage, acts to control and allocate resources of thecomputer system. System applications take advantage of the management ofresources by the operating system through program modules and programdata stored either in the system memory or on the disk storage. It is tobe appreciated that various components described herein can beimplemented with various operating systems or combinations of operatingsystems.

A user enters commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter is provided to illustrate that there are some output deviceslike monitors, displays, speakers, and printers, among other outputdevices that require special adapters. The output adapters include, byway of illustration and not limitation, video and sound cards thatprovide a means of connection between the output device and the systembus. It should be noted that other devices and/or systems of devices,such as remote computer(s), provide both input and output capabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, server, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) is logically connected to the computer system througha network interface and then physically connected via a communicationconnection. The network interface encompasses communication networkssuch as local area networks (LANs) and wide area networks (WANs). LANtechnologies include Fiber Distributed Data Interface (FDDI), CopperDistributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE802.5 and the like. WAN technologies include, but are not limited to,point-to-point links, circuit-switching networks like IntegratedServices Digital Networks (ISDN) and variations thereon,packet-switching networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 10, the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 9-10, may comprise an image processor, image-processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (SIMD)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image-processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) refers to the hardware/software employedto connect the network interface to the bus. While the communicationconnection is shown for illustrative clarity inside the computer system,it can also be external to the computer system 210. Thehardware/software necessary for connection to the network interfaceincludes, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

FIG. 11 illustrates a functional block diagram of one aspect of a USBnetwork hub 300 device, according to one aspect of the presentdisclosure. In the illustrated aspect, the USB network hub device 300employs a TUSB2036 integrated circuit hub by Texas Instruments. The USBnetwork hub 300 is a CMOS device that provides an upstream USBtransceiver port 302 and up to three downstream USB transceiver ports304, 306, 308 in compliance with the USB 2.0 specification. The upstreamUSB transceiver port 302 is a differential root data port comprising adifferential data minus (DM0) input paired with a differential data plus(DP0) input. The three downstream USB transceiver ports 304, 306, 308are differential data ports where each port includes differential dataplus (DP1−DP3) outputs paired with differential data minus (DM1−DM3)outputs.

The USB network hub 300 device is implemented with a digital statemachine instead of a microcontroller, and no firmware programming isrequired. Fully compliant USB transceivers are integrated into thecircuit for the upstream USB transceiver port 302 and all downstream USBtransceiver ports 304, 306, 308. The downstream USB transceiver ports304, 306, 308 support both full-speed and low-speed devices byautomatically setting the slew rate according to the speed of the deviceattached to the ports. The USB network hub 300 device may be configuredeither in bus-powered or self-powered mode and includes a hub powerlogic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310(SIE). The SIE 310 is the front end of the USB network hub 300 hardwareand handles most of the protocol described in chapter 8 of the USBspecification. The SIE 310 typically comprehends signaling up to thetransaction level. The functions that it handles could include: packetrecognition, transaction sequencing, SOP, EOP, RESET, and RESUME signaldetection/generation, clock/data separation, non-return-to-zero invert(NRZI) data encoding/decoding and bit-stuffing, CRC generation andchecking (token and data), packet ID (PID) generation andchecking/decoding, and/or serial-parallel/parallel-serial conversion.The 310 receives a clock input 314 and is coupled to a suspend/resumelogic and frame timer 316 circuit and a hub repeater circuit 318 tocontrol communication between the upstream USB transceiver port 302 andthe downstream USB transceiver ports 304, 306, 308 through port logiccircuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326via interface logic to control commands from a serial EEPROM via aserial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functionsconfigured in up to six logical layers (tiers) to a single computer.Further, the USB network hub 300 can connect to all peripherals using astandardized four-wire cable that provides both communication and powerdistribution. The power configurations are bus-powered and self-poweredmodes. The USB network hub 300 may be configured to support four modesof power management: a bus-powered hub, with either individual-portpower management or ganged-port power management, and the self-poweredhub, with either individual-port power management or ganged-port powermanagement. In one aspect, using a USB cable, the USB network hub 300,the upstream USB transceiver port 302 is plugged into a USB hostcontroller, and the downstream USB transceiver ports 304, 306, 308 areexposed for connecting USB compatible devices, and so forth.

Surgical Instrument Hardware

FIG. 12 illustrates a logic diagram of a control system 470 of asurgical instrument or tool in accordance with one or more aspects ofthe present disclosure. The system 470 comprises a control circuit. Thecontrol circuit includes a microcontroller 461 comprising a processor462 and a memory 468. One or more of sensors 472, 474, 476, for example,provide real-time feedback to the processor 462. A motor 482, driven bya motor driver 492, operably couples a longitudinally movabledisplacement member to drive the I-beam knife element. A tracking system480 is configured to determine the position of the longitudinallymovable displacement member. The position information is provided to theprocessor 462, which can be programmed or configured to determine theposition of the longitudinally movable drive member as well as theposition of a firing member, firing bar, and I-beam knife element.Additional motors may be provided at the tool driver interface tocontrol I-beam firing, closure tube travel, shaft rotation, andarticulation. A display 473 displays a variety of operating conditionsof the instruments and may include touch screen functionality for datainput. Information displayed on the display 473 may be overlaid withimages acquired via endoscopic imaging modules.

In one aspect, the microcontroller 461 may be any single-core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one aspect, the main microcontroller 461 may bean LM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising an on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle SRAM, and internal ROM loaded with StellarisWare® software,a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and/orone or more 12-bit ADCs with 12 analog input channels, details of whichare available for the product datasheet.

In one aspect, the microcontroller 461 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The microcontroller 461 may be programmed to perform various functionssuch as precise control over the speed and position of the knife andarticulation systems. In one aspect, the microcontroller 461 includes aprocessor 462 and a memory 468. The electric motor 482 may be a brusheddirect current (DC) motor with a gearbox and mechanical links to anarticulation or knife system. In one aspect, a motor driver 492 may bean A3941 available from Allegro Microsystems, Inc. Other motor driversmay be readily substituted for use in the tracking system 480 comprisingan absolute positioning system. A detailed description of an absolutepositioning system is described in U.S. Patent Application PublicationNo. 2017/0296213, titled SYSTEMS AND METHODS FOR CONTROLLING A SURGICALSTAPLING AND CUTTING INSTRUMENT, which published on Oct. 19, 2017, whichis herein incorporated by reference in its entirety.

The microcontroller 461 may be programmed to provide precise controlover the speed and position of displacement members and articulationsystems. The microcontroller 461 may be configured to compute a responsein the software of the microcontroller 461. The computed response iscompared to a measured response of the actual system to obtain an“observed” response, which is used for actual feedback decisions. Theobserved response is a favorable, tuned value that balances the smooth,continuous nature of the simulated response with the measured response,which can detect outside influences on the system.

In one aspect, the motor 482 may be controlled by the motor driver 492and can be employed by the firing system of the surgical instrument ortool. In various forms, the motor 482 may be a brushed DC driving motorhaving a maximum rotational speed of approximately 25,000 RPM. In otherarrangements, the motor 482 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 492 may comprise an H-bridge drivercomprising field-effect transistors (FETs), for example. The motor 482can be powered by a power assembly releasably mounted to the handleassembly or tool housing for supplying control power to the surgicalinstrument or tool. The power assembly may comprise a battery which mayinclude a number of battery cells connected in series that can be usedas the power source to power the surgical instrument or tool. In certaincircumstances, the battery cells of the power assembly may bereplaceable and/or rechargeable. In at least one example, the batterycells can be lithium-ion batteries which can be couplable to andseparable from the power assembly.

The motor driver 492 may be an A3941 available from AllegroMicrosystems, Inc. The A3941 492 is a full-bridge controller for usewith external N-channel power metal-oxide semiconductor field-effecttransistors (MOSFETs) specifically designed for inductive loads, such asbrush DC motors. The driver 492 comprises a unique charge pump regulatorthat provides full (>10 V) gate drive for battery voltages down to 7 Vand allows the A3941 to operate with a reduced gate drive, down to 5.5V. A bootstrap capacitor may be employed to provide the above batterysupply voltage required for N-channel MOSFETs. An internal charge pumpfor the high-side drive allows DC (100% duty cycle) operation. The fullbridge can be driven in fast or slow decay modes using diode orsynchronous rectification. In the slow decay mode, current recirculationcan be through the high-side or the lowside FETs. The power FETs areprotected from shoot-through by resistor-adjustable dead time.Integrated diagnostics provide indications of undervoltage,overtemperature, and power bridge faults and can be configured toprotect the power MOSFETs under most short circuit conditions. Othermotor drivers may be readily substituted for use in the tracking system480 comprising an absolute positioning system.

The tracking system 480 comprises a controlled motor drive circuitarrangement comprising a position sensor 472 according to one aspect ofthis disclosure. The position sensor 472 for an absolute positioningsystem provides a unique position signal corresponding to the locationof a displacement member. In one aspect, the displacement memberrepresents a longitudinally movable drive member comprising a rack ofdrive teeth for meshing engagement with a corresponding drive gear of agear reducer assembly. In other aspects, the displacement memberrepresents the firing member, which could be adapted and configured toinclude a rack of drive teeth. In yet another aspect, the displacementmember represents a firing bar or the I-beam, each of which can beadapted and configured to include a rack of drive teeth. Accordingly, asused herein, the term displacement member is used generically to referto any movable member of the surgical instrument or tool such as thedrive member, the firing member, the firing bar, the I-beam, or anyelement that can be displaced. In one aspect, the longitudinally movabledrive member is coupled to the firing member, the firing bar, and theI-beam. Accordingly, the absolute positioning system can, in effect,track the linear displacement of the I-beam by tracking the lineardisplacement of the longitudinally movable drive member. In variousother aspects, the displacement member may be coupled to any positionsensor 472 suitable for measuring linear displacement. Thus, thelongitudinally movable drive member, the firing member, the firing bar,or the I-beam, or combinations thereof, may be coupled to any suitablelinear displacement sensor. Linear displacement sensors may includecontact or non-contact displacement sensors. Linear displacement sensorsmay comprise linear variable differential transformers (LVDT),differential variable reluctance transducers (DVRT), a slidepotentiometer, a magnetic sensing system comprising a movable magnet anda series of linearly arranged Hall effect sensors, a magnetic sensingsystem comprising a fixed magnet and a series of movable, linearlyarranged Hall effect sensors, an optical sensing system comprising amovable light source and a series of linearly arranged photo diodes orphoto detectors, an optical sensing system comprising a fixed lightsource and a series of movable linearly, arranged photo diodes or photodetectors, or any combination thereof.

The electric motor 482 can include a rotatable shaft that operablyinterfaces with a gear assembly that is mounted in meshing engagementwith a set, or rack, of drive teeth on the displacement member. A sensorelement may be operably coupled to a gear assembly such that a singlerevolution of the position sensor 472 element corresponds to some linearlongitudinal translation of the displacement member. An arrangement ofgearing and sensors can be connected to the linear actuator, via a rackand pinion arrangement, or a rotary actuator, via a spur gear or otherconnection. A power source supplies power to the absolute positioningsystem and an output indicator may display the output of the absolutepositioning system. The displacement member represents thelongitudinally movable drive member comprising a rack of drive teethformed thereon for meshing engagement with a corresponding drive gear ofthe gear reducer assembly. The displacement member represents thelongitudinally movable firing member, firing bar, I-beam, orcombinations thereof.

A single revolution of the sensor element associated with the positionsensor 472 is equivalent to a longitudinal linear displacement d1 of theof the displacement member, where d1 is the longitudinal linear distancethat the displacement member moves from point “a” to point “b” after asingle revolution of the sensor element coupled to the displacementmember. The sensor arrangement may be connected via a gear reductionthat results in the position sensor 472 completing one or morerevolutions for the full stroke of the displacement member. The positionsensor 472 may complete multiple revolutions for the full stroke of thedisplacement member.

A series of switches, where n is an integer greater than one, may beemployed alone or in combination with a gear reduction to provide aunique position signal for more than one revolution of the positionsensor 472. The state of the switches are fed back to themicrocontroller 461 that applies logic to determine a unique positionsignal corresponding to the longitudinal linear displacement d1+d2+ . .. dn of the displacement member. The output of the position sensor 472is provided to the microcontroller 461. The position sensor 472 of thesensor arrangement may comprise a magnetic sensor, an analog rotarysensor like a potentiometer, or an array of analog Hall-effect elements,which output a unique combination of position signals or values.

The position sensor 472 may comprise any number of magnetic sensingelements, such as, for example, magnetic sensors classified according towhether they measure the total magnetic field or the vector componentsof the magnetic field. The techniques used to produce both types ofmagnetic sensors encompass many aspects of physics and electronics. Thetechnologies used for magnetic field sensing include search coil,fluxgate, optically pumped, nuclear precession, SQUID, Hall-effect,anisotropic magnetoresistance, giant magnetoresistance, magnetic tunneljunctions, giant magnetoimpedance, magnetostrictive/piezoelectriccomposites, magnetodiode, magnetotransistor, fiber-optic, magneto-optic,and microelectromechanical systems-based magnetic sensors, among others.

In one aspect, the position sensor 472 for the tracking system 480comprising an absolute positioning system comprises a magnetic rotaryabsolute positioning system. The position sensor 472 may be implementedas an AS5055EQFT single-chip magnetic rotary position sensor availablefrom Austria Microsystems, AG. The position sensor 472 is interfacedwith the microcontroller 461 to provide an absolute positioning system.The position sensor 472 is a low-voltage and low-power component andincludes four Hall-effect elements in an area of the position sensor 472that is located above a magnet. A high-resolution ADC and a smart powermanagement controller are also provided on the chip. A coordinaterotation digital computer (CORDIC) processor, also known as thedigit-by-digit method and Volder's algorithm, is provided to implement asimple and efficient algorithm to calculate hyperbolic and trigonometricfunctions that require only addition, subtraction, bitshift, and tablelookup operations. The angle position, alarm bits, and magnetic fieldinformation are transmitted over a standard serial communicationinterface, such as a serial peripheral interface (SPI) interface, to themicrocontroller 461. The position sensor 472 provides 12 or 14 bits ofresolution. The position sensor 472 may be an AS5055 chip provided in asmall QFN 16-pin 4×4×0.85 mm package.

The tracking system 480 comprising an absolute positioning system maycomprise and/or be programmed to implement a feedback controller, suchas a PID, state feedback, and adaptive controller. A power sourceconverts the signal from the feedback controller into a physical inputto the system: in this case the voltage. Other examples include a PWM ofthe voltage, current, and force. Other sensor(s) may be provided tomeasure physical parameters of the physical system in addition to theposition measured by the position sensor 472. In some aspects, the othersensor(s) can include sensor arrangements such as those described inU.S. Pat. No. 9,345,481, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM, which issued on May 24, 2016, which is herein incorporated byreference in its entirety; U.S. Patent Application Publication No.2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,which published on Sep. 18, 2014, which is herein incorporated byreference in its entirety; and U.S. patent application Ser. No.15/628,175, titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OFA SURGICAL STAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, whichis herein incorporated by reference in its entirety. In a digital signalprocessing system, an absolute positioning system is coupled to adigital data acquisition system where the output of the absolutepositioning system will have a finite resolution and sampling frequency.The absolute positioning system may comprise a compare-and-combinecircuit to combine a computed response with a measured response usingalgorithms, such as a weighted average and a theoretical control loop,that drive the computed response towards the measured response. Thecomputed response of the physical system takes into account propertieslike mass, inertial, viscous friction, inductance resistance, etc., topredict what the states and outputs of the physical system will be byknowing the input.

The absolute positioning system provides an absolute position of thedisplacement member upon power-up of the instrument, without retractingor advancing the displacement member to a reset (zero or home) positionas may be required with conventional rotary encoders that merely countthe number of steps forwards or backwards that the motor 482 has takento infer the position of a device actuator, drive bar, knife, or thelike.

A sensor 474, such as, for example, a strain gauge or a micro-straingauge, is configured to measure one or more parameters of the endeffector, such as, for example, the amplitude of the strain exerted onthe anvil during a clamping operation, which can be indicative of theclosure forces applied to the anvil. The measured strain is converted toa digital signal and provided to the processor 462. Alternatively, or inaddition to the sensor 474, a sensor 476, such as, for example, a loadsensor, can measure the closure force applied by the closure drivesystem to the anvil. The sensor 476, such as, for example, a loadsensor, can measure the firing force applied to an I-beam in a firingstroke of the surgical instrument or tool. The I-beam is configured toengage a wedge sled, which is configured to upwardly cam staple driversto force out staples into deforming contact with an anvil. The I-beamalso includes a sharpened cutting edge that can be used to sever tissueas the I-beam is advanced distally by the firing bar. Alternatively, acurrent sensor 478 can be employed to measure the current drawn by themotor 482. The force required to advance the firing member cancorrespond to the current drawn by the motor 482, for example. Themeasured force is converted to a digital signal and provided to theprocessor 462.

In one form, the strain gauge sensor 474 can be used to measure theforce applied to the tissue by the end effector. A strain gauge can becoupled to the end effector to measure the force on the tissue beingtreated by the end effector. A system for measuring forces applied tothe tissue grasped by the end effector comprises a strain gauge sensor474, such as, for example, a micro-strain gauge, that is configured tomeasure one or more parameters of the end effector, for example. In oneaspect, the strain gauge sensor 474 can measure the amplitude ormagnitude of the strain exerted on a jaw member of an end effectorduring a clamping operation, which can be indicative of the tissuecompression. The measured strain is converted to a digital signal andprovided to a processor 462 of the microcontroller 461. A load sensor476 can measure the force used to operate the knife element, forexample, to cut the tissue captured between the anvil and the staplecartridge. A magnetic field sensor can be employed to measure thethickness of the captured tissue. The measurement of the magnetic fieldsensor also may be converted to a digital signal and provided to theprocessor 462.

The measurements of the tissue compression, the tissue thickness, and/orthe force required to close the end effector on the tissue, asrespectively measured by the sensors 474, 476, can be used by themicrocontroller 461 to characterize the selected position of the firingmember and/or the corresponding value of the speed of the firing member.In one instance, a memory 468 may store a technique, an equation, and/ora lookup table which can be employed by the microcontroller 461 in theassessment.

The control system 470 of the surgical instrument or tool also maycomprise wired or wireless communication circuits to communicate withthe modular communication hub as shown in FIGS. 8-11.

FIG. 13 illustrates a control circuit 500 configured to control aspectsof the surgical instrument or tool according to one aspect of thisdisclosure. The control circuit 500 can be configured to implementvarious processes described herein. The control circuit 500 may comprisea microcontroller comprising one or more processors 502 (e.g.,microprocessor, microcontroller) coupled to at least one memory circuit504. The memory circuit 504 stores machine-executable instructions that,when executed by the processor 502, cause the processor 502 to executemachine instructions to implement various processes described herein.The processor 502 may be any one of a number of single-core or multicoreprocessors known in the art. The memory circuit 504 may comprisevolatile and non-volatile storage media. The processor 502 may includean instruction processing unit 506 and an arithmetic unit 508. Theinstruction processing unit may be configured to receive instructionsfrom the memory circuit 504 of this disclosure.

FIG. 14 illustrates a combinational logic circuit 510 configured tocontrol aspects of the surgical instrument or tool according to oneaspect of this disclosure. The combinational logic circuit 510 can beconfigured to implement various processes described herein. Thecombinational logic circuit 510 may comprise a finite state machinecomprising a combinational logic 512 configured to receive dataassociated with the surgical instrument or tool at an input 514, processthe data by the combinational logic 512, and provide an output 516.

FIG. 15 illustrates a sequential logic circuit 520 configured to controlaspects of the surgical instrument or tool according to one aspect ofthis disclosure. The sequential logic circuit 520 or the combinationallogic 522 can be configured to implement various processes describedherein. The sequential logic circuit 520 may comprise a finite statemachine. The sequential logic circuit 520 may comprise a combinationallogic 522, at least one memory circuit 524, and a clock 529, forexample. The at least one memory circuit 524 can store a current stateof the finite state machine. In certain instances, the sequential logiccircuit 520 may be synchronous or asynchronous. The combinational logic522 is configured to receive data associated with the surgicalinstrument or tool from an input 526, process the data by thecombinational logic 522, and provide an output 528. In other aspects,the circuit may comprise a combination of a processor (e.g., processor502, FIG. 13) and a finite state machine to implement various processesherein. In other aspects, the finite state machine may comprise acombination of a combinational logic circuit (e.g., combinational logiccircuit 510, FIG. 14) and the sequential logic circuit 520.

FIG. 16 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions. Incertain instances, a first motor can be activated to perform a firstfunction, a second motor can be activated to perform a second function,a third motor can be activated to perform a third function, a fourthmotor can be activated to perform a fourth function, and so on. Incertain instances, the plurality of motors of robotic surgicalinstrument 600 can be individually activated to cause firing, closure,and/or articulation motions in the end effector. The firing, closure,and/or articulation motions can be transmitted to the end effectorthrough a shaft assembly, for example.

In certain instances, the surgical instrument system or tool may includea firing motor 602. The firing motor 602 may be operably coupled to afiring motor drive assembly 604 which can be configured to transmitfiring motions, generated by the motor 602 to the end effector, inparticular to displace the I-beam element. In certain instances, thefiring motions generated by the motor 602 may cause the staples to bedeployed from the staple cartridge into tissue captured by the endeffector and/or the cutting edge of the I-beam element to be advanced tocut the captured tissue, for example. The I-beam element may beretracted by reversing the direction of the motor 602.

In certain instances, the surgical instrument or tool may include aclosure motor 603. The closure motor 603 may be operably coupled to aclosure motor drive assembly 605 which can be configured to transmitclosure motions, generated by the motor 603 to the end effector, inparticular to displace a closure tube to close the anvil and compresstissue between the anvil and the staple cartridge. The closure motionsmay cause the end effector to transition from an open configuration toan approximated configuration to capture tissue, for example. The endeffector may be transitioned to an open position by reversing thedirection of the motor 603.

In certain instances, the surgical instrument or tool may include one ormore articulation motors 606 a, 606 b, for example. The motors 606 a,606 b may be operably coupled to respective articulation motor driveassemblies 608 a, 608 b, which can be configured to transmitarticulation motions generated by the motors 606 a, 606 b to the endeffector. In certain instances, the articulation motions may cause theend effector to articulate relative to the shaft, for example.

As described above, the surgical instrument or tool may include aplurality of motors which may be configured to perform variousindependent functions. In certain instances, the plurality of motors ofthe surgical instrument or tool can be individually or separatelyactivated to perform one or more functions while the other motors remaininactive. For example, the articulation motors 606 a, 606 b can beactivated to cause the end effector to be articulated while the firingmotor 602 remains inactive. Alternatively, the firing motor 602 can beactivated to fire the plurality of staples, and/or to advance thecutting edge, while the articulation motor 606 remains inactive.Furthermore, the closure motor 603 may be activated simultaneously withthe firing motor 602 to cause the closure tube and the I-beam element toadvance distally as described in more detail hereinbelow.

In certain instances, the surgical instrument or tool may include acommon control module 610 which can be employed with a plurality ofmotors of the surgical instrument or tool. In certain instances, thecommon control module 610 may accommodate one of the plurality of motorsat a time. For example, the common control module 610 can be couplableto and separable from the plurality of motors of the robotic surgicalinstrument individually. In certain instances, a plurality of the motorsof the surgical instrument or tool may share one or more common controlmodules such as the common control module 610. In certain instances, aplurality of motors of the surgical instrument or tool can beindividually and selectively engaged with the common control module 610.In certain instances, the common control module 610 can be selectivelyswitched from interfacing with one of a plurality of motors of thesurgical instrument or tool to interfacing with another one of theplurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 can beselectively switched between operable engagement with the articulationmotors 606 a, 606 b and operable engagement with either the firing motor602 or the closure motor 603. In at least one example, as illustrated inFIG. 16, a switch 614 can be moved or transitioned between a pluralityof positions and/or states. In a first position 616, the switch 614 mayelectrically couple the common control module 610 to the firing motor602; in a second position 617, the switch 614 may electrically couplethe common control module 610 to the closure motor 603; in a thirdposition 618 a, the switch 614 may electrically couple the commoncontrol module 610 to the first articulation motor 606 a; and in afourth position 618 b, the switch 614 may electrically couple the commoncontrol module 610 to the second articulation motor 606 b, for example.In certain instances, separate common control modules 610 can beelectrically coupled to the firing motor 602, the closure motor 603, andthe articulations motor 606 a, 606 b at the same time. In certaininstances, the switch 614 may be a mechanical switch, anelectromechanical switch, a solid-state switch, or any suitableswitching mechanism.

Each of the motors 602, 603, 606 a, 606 b may comprise a torque sensorto measure the output torque on the shaft of the motor. The force on anend effector may be sensed in any conventional manner, such as by forcesensors on the outer sides of the jaws or by a torque sensor for themotor actuating the jaws.

In various instances, as illustrated in FIG. 16, the common controlmodule 610 may comprise a motor driver 626 which may comprise one ormore H-Bridge FETs. The motor driver 626 may modulate the powertransmitted from a power source 628 to a motor coupled to the commoncontrol module 610 based on input from a microcontroller 620 (the“controller”), for example. In certain instances, the microcontroller620 can be employed to determine the current drawn by the motor, forexample, while the motor is coupled to the common control module 610, asdescribed above.

In certain instances, the microcontroller 620 may include amicroprocessor 622 (the “processor”) and one or more non-transitorycomputer-readable mediums or memory units 624 (the “memory”). In certaininstances, the memory 624 may store various program instructions, whichwhen executed may cause the processor 622 to perform a plurality offunctions and/or calculations described herein. In certain instances,one or more of the memory units 624 may be coupled to the processor 622,for example.

In certain instances, the power source 628 can be employed to supplypower to the microcontroller 620, for example. In certain instances, thepower source 628 may comprise a battery (or “battery pack” or “powerpack”), such as a lithium-ion battery, for example. In certaininstances, the battery pack may be configured to be releasably mountedto a handle for supplying power to the surgical instrument 600. A numberof battery cells connected in series may be used as the power source628. In certain instances, the power source 628 may be replaceableand/or rechargeable, for example.

In various instances, the processor 622 may control the motor driver 626to control the position, direction of rotation, and/or velocity of amotor that is coupled to the common control module 610. In certaininstances, the processor 622 can signal the motor driver 626 to stopand/or disable a motor that is coupled to the common control module 610.It should be understood that the term “processor” as used hereinincludes any suitable microprocessor, microcontroller, or other basiccomputing device that incorporates the functions of a computer's centralprocessing unit (CPU) on an integrated circuit or, at most, a fewintegrated circuits. The processor is a multipurpose, programmabledevice that accepts digital data as input, processes it according toinstructions stored in its memory, and provides results as output. It isan example of sequential digital logic, as it has internal memory.Processors operate on numbers and symbols represented in the binarynumeral system.

In one instance, the processor 622 may be any single-core or multicoreprocessor such as those known under the trade name ARM Cortex by TexasInstruments. In certain instances, the microcontroller 620 may be an LM4F230H5QR, available from Texas Instruments, for example. In at leastone example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4FProcessor Core comprising an on-chip memory of 256 KB single-cycle flashmemory, or other non-volatile memory, up to 40 MHz, a prefetch buffer toimprove performance above 40 MHz, a 32 KB single-cycle SRAM, an internalROM loaded with StellarisWare® software, a 2 KB EEPROM, one or more PWMmodules, one or more QEI analogs, one or more 12-bit ADCs with 12 analoginput channels, among other features that are readily available for theproduct datasheet. Other microcontrollers may be readily substituted foruse with the module 4410. Accordingly, the present disclosure should notbe limited in this context.

In certain instances, the memory 624 may include program instructionsfor controlling each of the motors of the surgical instrument 600 thatare couplable to the common control module 610. For example, the memory624 may include program instructions for controlling the firing motor602, the closure motor 603, and the articulation motors 606 a, 606 b.Such program instructions may cause the processor 622 to control thefiring, closure, and articulation functions in accordance with inputsfrom algorithms or control programs of the surgical instrument or tool.

In certain instances, one or more mechanisms and/or sensors such as, forexample, sensors 630 can be employed to alert the processor 622 to theprogram instructions that should be used in a particular setting. Forexample, the sensors 630 may alert the processor 622 to use the programinstructions associated with firing, closing, and articulating the endeffector. In certain instances, the sensors 630 may comprise positionsensors which can be employed to sense the position of the switch 614,for example. Accordingly, the processor 622 may use the programinstructions associated with firing the I-beam of the end effector upondetecting, through the sensors 630 for example, that the switch 614 isin the first position 616; the processor 622 may use the programinstructions associated with closing the anvil upon detecting, throughthe sensors 630 for example, that the switch 614 is in the secondposition 617; and the processor 622 may use the program instructionsassociated with articulating the end effector upon detecting, throughthe sensors 630 for example, that the switch 614 is in the third orfourth position 618 a, 618 b.

FIG. 17 is a schematic diagram of a robotic surgical instrument 700configured to operate a surgical tool described herein according to oneaspect of this disclosure. The robotic surgical instrument 700 may beprogrammed or configured to control distal/proximal translation of adisplacement member, distal/proximal displacement of a closure tube,shaft rotation, and articulation, either with single or multiplearticulation drive links. In one aspect, the surgical instrument 700 maybe programmed or configured to individually control a firing member, aclosure member, a shaft member, and/or one or more articulation members.The surgical instrument 700 comprises a control circuit 710 configuredto control motor-driven firing members, closure members, shaft members,and/or one or more articulation members.

In one aspect, the robotic surgical instrument 700 comprises a controlcircuit 710 configured to control an anvil 716 and an I-beam 714(including a sharp cutting edge) portion of an end effector 702, aremovable staple cartridge 718, a shaft 740, and one or morearticulation members 742 a, 742 b via a plurality of motors 704 a-704 e.A position sensor 734 may be configured to provide position feedback ofthe I-beam 714 to the control circuit 710. Other sensors 738 may beconfigured to provide feedback to the control circuit 710. Atimer/counter 731 provides timing and counting information to thecontrol circuit 710. An energy source 712 may be provided to operate themotors 704 a-704 e, and a current sensor 736 provides motor currentfeedback to the control circuit 710. The motors 704 a-704 e can beoperated individually by the control circuit 710 in an open-loop orclosed-loop feedback control.

In one aspect, the control circuit 710 may comprise one or moremicrocontrollers, microprocessors, or other suitable processors forexecuting instructions that cause the processor or processors to performone or more tasks. In one aspect, a timer/counter 731 provides an outputsignal, such as the elapsed time or a digital count, to the controlcircuit 710 to correlate the position of the I-beam 714 as determined bythe position sensor 734 with the output of the timer/counter 731 suchthat the control circuit 710 can determine the position of the I-beam714 at a specific time (t) relative to a starting position or the time(t) when the I-beam 714 is at a specific position relative to a startingposition. The timer/counter 731 may be configured to measure elapsedtime, count external events, or time external events.

In one aspect, the control circuit 710 may be programmed to controlfunctions of the end effector 702 based on one or more tissueconditions. The control circuit 710 may be programmed to sense tissueconditions, such as thickness, either directly or indirectly, asdescribed herein. The control circuit 710 may be programmed to select afiring control program or closure control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 710 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 710 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power. A closure control program may control theclosure force applied to the tissue by the anvil 716. Other controlprograms control the rotation of the shaft 740 and the articulationmembers 742 a, 742 b.

In one aspect, the control circuit 710 may generate motor set pointsignals. The motor set point signals may be provided to various motorcontrollers 708 a-708 e. The motor controllers 708 a-708 e may compriseone or more circuits configured to provide motor drive signals to themotors 704 a-704 e to drive the motors 704 a-704 e as described herein.In some examples, the motors 704 a-704 e may be brushed DC electricmotors. For example, the velocity of the motors 704 a-704 e may beproportional to the respective motor drive signals. In some examples,the motors 704 a-704 e may be brushless DC electric motors, and therespective motor drive signals may comprise a PWM signal provided to oneor more stator windings of the motors 704 a-704 e. Also, in someexamples, the motor controllers 708 a-708 e may be omitted and thecontrol circuit 710 may generate the motor drive signals directly.

In one aspect, the control circuit 710 may initially operate each of themotors 704 a-704 e in an open-loop configuration for a first open-loopportion of a stroke of the displacement member. Based on the response ofthe robotic surgical instrument 700 during the open-loop portion of thestroke, the control circuit 710 may select a firing control program in aclosed-loop configuration. The response of the instrument may include atranslation distance of the displacement member during the open-loopportion, a time elapsed during the open-loop portion, the energyprovided to one of the motors 704 a-704 e during the open-loop portion,a sum of pulse widths of a motor drive signal, etc. After the open-loopportion, the control circuit 710 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during a closed-loop portion of the stroke, the controlcircuit 710 may modulate one of the motors 704 a-704 e based ontranslation data describing a position of the displacement member in aclosed-loop manner to translate the displacement member at a constantvelocity.

In one aspect, the motors 704 a-704 e may receive power from an energysource 712. The energy source 712 may be a DC power supply driven by amain alternating current power source, a battery, a super capacitor, orany other suitable energy source. The motors 704 a-704 e may bemechanically coupled to individual movable mechanical elements such asthe !-beam 714, anvil 716, shaft 740, articulation 742 a, andarticulation 742 b via respective transmissions 706 a-706 e. Thetransmissions 706 a-706 e may include one or more gears or other linkagecomponents to couple the motors 704 a-704 e to movable mechanicalelements. A position sensor 734 may sense a position of the I-beam 714.The position sensor 734 may be or include any type of sensor that iscapable of generating position data that indicate a position of theI-beam 714. In some examples, the position sensor 734 may include anencoder configured to provide a series of pulses to the control circuit710 as the I-beam 714 translates distally and proximally. The controlcircuit 710 may track the pulses to determine the position of the I-beam714. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 714. Also, in someexamples, the position sensor 734 may be omitted. Where any of themotors 704 a-704 e is a stepper motor, the control circuit 710 may trackthe position of the I-beam 714 by aggregating the number and directionof steps that the motor 704 has been instructed to execute. The positionsensor 734 may be located in the end effector 702 or at any otherportion of the instrument. The outputs of each of the motors 704 a-704 einclude a torque sensor 744 a-744 e to sense force and have an encoderto sense rotation of the drive shaft.

In one aspect, the control circuit 710 is configured to drive a firingmember such as the I-beam 714 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 a,which provides a drive signal to the motor 704 a. The output shaft ofthe motor 704 a is coupled to a torque sensor 744 a. The torque sensor744 a is coupled to a transmission 706 a which is coupled to the I-beam714. The transmission 706 a comprises movable mechanical elements suchas rotating elements and a firing member to control the movement of theI-beam 714 distally and proximally along a longitudinal axis of the endeffector 702. In one aspect, the motor 704 a may be coupled to the knifegear assembly, which includes a knife gear reduction set that includes afirst knife drive gear and a second knife drive gear. A torque sensor744 a provides a firing force feedback signal to the control circuit710. The firing force signal represents the force required to fire ordisplace the I-beam 714. A position sensor 734 may be configured toprovide the position of the I-beam 714 along the firing stroke or theposition of the firing member as a feedback signal to the controlcircuit 710. The end effector 702 may include additional sensors 738configured to provide feedback signals to the control circuit 710. Whenready to use, the control circuit 710 may provide a firing signal to themotor control 708 a. In response to the firing signal, the motor 704 amay drive the firing member distally along the longitudinal axis of theend effector 702 from a proximal stroke start position to a stroke endposition distal to the stroke start position. As the firing membertranslates distally, an I-beam 714, with a cutting element positioned ata distal end, advances distally to cut tissue located between the staplecartridge 718 and the anvil 716.

In one aspect, the control circuit 710 is configured to drive a closuremember such as the anvil 716 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 b,which provides a drive signal to the motor 704 b. The output shaft ofthe motor 704 b is coupled to a torque sensor 744 b. The torque sensor744 b is coupled to a transmission 706 b which is coupled to the anvil716. The transmission 706 b comprises movable mechanical elements suchas rotating elements and a closure member to control the movement of theanvil 716 from the open and closed positions. In one aspect, the motor704 b is coupled to a closure gear assembly, which includes a closurereduction gear set that is supported in meshing engagement with theclosure spur gear. The torque sensor 744 b provides a closure forcefeedback signal to the control circuit 710. The closure force feedbacksignal represents the closure force applied to the anvil 716. Theposition sensor 734 may be configured to provide the position of theclosure member as a feedback signal to the control circuit 710.Additional sensors 738 in the end effector 702 may provide the closureforce feedback signal to the control circuit 710. The pivotable anvil716 is positioned opposite the staple cartridge 718. When ready to use,the control circuit 710 may provide a closure signal to the motorcontrol 708 b. In response to the closure signal, the motor 704 badvances a closure member to grasp tissue between the anvil 716 and thestaple cartridge 718.

In one aspect, the control circuit 710 is configured to rotate a shaftmember such as the shaft 740 to rotate the end effector 702. The controlcircuit 710 provides a motor set point to a motor control 708 c, whichprovides a drive signal to the motor 704 c. The output shaft of themotor 704 c is coupled to a torque sensor 744 c. The torque sensor 744 cis coupled to a transmission 706 c which is coupled to the shaft 740.The transmission 706 c comprises movable mechanical elements such asrotating elements to control the rotation of the shaft 740 clockwise orcounterclockwise up to and over 360°. In one aspect, the motor 704 c iscoupled to the rotational transmission assembly, which includes a tubegear segment that is formed on (or attached to) the proximal end of theproximal closure tube for operable engagement by a rotational gearassembly that is operably supported on the tool mounting plate. Thetorque sensor 744 c provides a rotation force feedback signal to thecontrol circuit 710. The rotation force feedback signal represents therotation force applied to the shaft 740. The position sensor 734 may beconfigured to provide the position of the closure member as a feedbacksignal to the control circuit 710. Additional sensors 738 such as ashaft encoder may provide the rotational position of the shaft 740 tothe control circuit 710.

In one aspect, the control circuit 710 is configured to articulate theend effector 702. The control circuit 710 provides a motor set point toa motor control 708 d, which provides a drive signal to the motor 704 d.The output shaft of the motor 704 d is coupled to a torque sensor 744 d.The torque sensor 744 d is coupled to a transmission 706 d which iscoupled to an articulation member 742 a. The transmission 706 dcomprises movable mechanical elements such as articulation elements tocontrol the articulation of the end effector 702 ±65°. In one aspect,the motor 704 d is coupled to an articulation nut, which is rotatablyjournaled on the proximal end portion of the distal spine portion and isrotatably driven thereon by an articulation gear assembly. The torquesensor 744 d provides an articulation force feedback signal to thecontrol circuit 710. The articulation force feedback signal representsthe articulation force applied to the end effector 702. Sensors 738,such as an articulation encoder, may provide the articulation positionof the end effector 702 to the control circuit 710.

In another aspect, the articulation function of the robotic surgicalsystem 700 may comprise two articulation members, or links, 742 a, 742b. These articulation members 742 a, 742 b are driven by separate diskson the robot interface (the rack) which are driven by the two motors 708d, 708 e. When the separate firing motor 704 a is provided, each ofarticulation links 742 a, 742 b can be antagonistically driven withrespect to the other link in order to provide a resistive holding motionand a load to the head when it is not moving and to provide anarticulation motion as the head is articulated. The articulation members742 a, 742 b attach to the head at a fixed radius as the head isrotated. Accordingly, the mechanical advantage of the push-and-pull linkchanges as the head is rotated. This change in the mechanical advantagemay be more pronounced with other articulation link drive systems.

In one aspect, the one or more motors 704 a-704 e may comprise a brushedDC motor with a gearbox and mechanical links to a firing member, closuremember, or articulation member. Another example includes electric motors704 a-704 e that operate the movable mechanical elements such as thedisplacement member, articulation links, closure tube, and shaft. Anoutside influence is an unmeasured, unpredictable influence of thingslike tissue, surrounding bodies, and friction on the physical system.Such outside influence can be referred to as drag, which acts inopposition to one of electric motors 704 a-704 e. The outside influence,such as drag, may cause the operation of the physical system to deviatefrom a desired operation of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolutepositioning system. In one aspect, the position sensor 734 may comprisea magnetic rotary absolute positioning system implemented as anAS5055EQFT single-chip magnetic rotary position sensor available fromAustria Microsystems, AG. The position sensor 734 may interface with thecontrol circuit 710 to provide an absolute positioning system. Theposition may include multiple Hall-effect elements located above amagnet and coupled to a CORDIC processor, also known as thedigit-by-digit method and Volder's algorithm, that is provided toimplement a simple and efficient algorithm to calculate hyperbolic andtrigonometric functions that require only addition, subtraction,bitshift, and table lookup operations.

In one aspect, the control circuit 710 may be in communication with oneor more sensors 738. The sensors 738 may be positioned on the endeffector 702 and adapted to operate with the robotic surgical instrument700 to measure the various derived parameters such as the gap distanceversus time, tissue compression versus time, and anvil strain versustime. The sensors 738 may comprise a magnetic sensor, a magnetic fieldsensor, a strain gauge, a load cell, a pressure sensor, a force sensor,a torque sensor, an inductive sensor such as an eddy current sensor, aresistive sensor, a capacitive sensor, an optical sensor, and/or anyother suitable sensor for measuring one or more parameters of the endeffector 702. The sensors 738 may include one or more sensors. Thesensors 738 may be located on the staple cartridge 718 deck to determinetissue location using segmented electrodes. The torque sensors 744 a-744e may be configured to sense force such as firing force, closure force,and/or articulation force, among others. Accordingly, the controlcircuit 710 can sense (1) the closure load experienced by the distalclosure tube and its position, (2) the firing member at the rack and itsposition, (3) what portion of the staple cartridge 718 has tissue on it,and (4) the load and position on both articulation rods.

In one aspect, the one or more sensors 738 may comprise a strain gauge,such as a micro-strain gauge, configured to measure the magnitude of thestrain in the anvil 716 during a clamped condition. The strain gaugeprovides an electrical signal whose amplitude varies with the magnitudeof the strain. The sensors 738 may comprise a pressure sensor configuredto detect a pressure generated by the presence of compressed tissuebetween the anvil 716 and the staple cartridge 718. The sensors 738 maybe configured to detect impedance of a tissue section located betweenthe anvil 716 and the staple cartridge 718 that is indicative of thethickness and/or fullness of tissue located therebetween.

In one aspect, the sensors 738 may be implemented as one or more limitswitches, electromechanical devices, solid-state switches, Hall-effectdevices, magneto-resistive (MR) devices, giant magneto-resistive (GMR)devices, magnetometers, among others. In other implementations, thesensors 738 may be implemented as solid-state switches that operateunder the influence of light, such as optical sensors, IR sensors,ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors738 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the sensors 738 may be configured to measure forcesexerted on the anvil 716 by the closure drive system. For example, oneor more sensors 738 can be at an interaction point between the closuretube and the anvil 716 to detect the closure forces applied by theclosure tube to the anvil 716. The forces exerted on the anvil 716 canbe representative of the tissue compression experienced by the tissuesection captured between the anvil 716 and the staple cartridge 718. Theone or more sensors 738 can be positioned at various interaction pointsalong the closure drive system to detect the closure forces applied tothe anvil 716 by the closure drive system. The one or more sensors 738may be sampled in real time during a clamping operation by the processorof the control circuit 710. The control circuit 710 receives real-timesample measurements to provide and analyze time-based information andassess, in real time, closure forces applied to the anvil 716.

In one aspect, a current sensor 736 can be employed to measure thecurrent drawn by each of the motors 704 a-704 e. The force required toadvance any of the movable mechanical elements such as the I-beam 714corresponds to the current drawn by one of the motors 704 a-704 e. Theforce is converted to a digital signal and provided to the controlcircuit 710. The control circuit 710 can be configured to simulate theresponse of the actual system of the instrument in the software of thecontroller. A displacement member can be actuated to move an I-beam 714in the end effector 702 at or near a target velocity. The roboticsurgical instrument 700 can include a feedback controller, which can beone of any feedback controllers, including, but not limited to a PID, astate feedback, a linear-quadratic (LQR), and/or an adaptive controller,for example. The robotic surgical instrument 700 can include a powersource to convert the signal from the feedback controller into aphysical input such as case voltage, PWM voltage, frequency modulatedvoltage, current, torque, and/or force, for example. Additional detailsare disclosed in U.S. patent application Ser. No. 15/636,829, titledCLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT,filed Jun. 29, 2017, which is herein incorporated by reference in itsentirety.

FIG. 18 illustrates a block diagram of a surgical instrument 750programmed to control the distal translation of a displacement memberaccording to one aspect of this disclosure. In one aspect, the surgicalinstrument 750 is programmed to control the distal translation of adisplacement member such as the I-beam 764. The surgical instrument 750comprises an end effector 752 that may comprise an anvil 766, an I-beam764 (including a sharp cutting edge), and a removable staple cartridge768.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the I-beam 764, can be measured by anabsolute positioning system, sensor arrangement, and position sensor784. Because the I-beam 764 is coupled to a longitudinally movable drivemember, the position of the I-beam 764 can be determined by measuringthe position of the longitudinally movable drive member employing theposition sensor 784. Accordingly, in the following description, theposition, displacement, and/or translation of the !-beam 764 can beachieved by the position sensor 784 as described herein. A controlcircuit 760 may be programmed to control the translation of thedisplacement member, such as the I-beam 764. The control circuit 760, insome examples, may comprise one or more microcontrollers,microprocessors, or other suitable processors for executing instructionsthat cause the processor or processors to control the displacementmember, e.g., the I-beam 764, in the manner described. In one aspect, atimer/counter 781 provides an output signal, such as the elapsed time ora digital count, to the control circuit 760 to correlate the position ofthe I-beam 764 as determined by the position sensor 784 with the outputof the timer/counter 781 such that the control circuit 760 can determinethe position of the I-beam 764 at a specific time (t) relative to astarting position. The timer/counter 781 may be configured to measureelapsed time, count external events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theI-beam 764 via a transmission 756. The transmission 756 may include oneor more gears or other linkage components to couple the motor 754 to theI-beam 764. A position sensor 784 may sense a position of the I-beam764. The position sensor 784 may be or include any type of sensor thatis capable of generating position data that indicate a position of theI-beam 764. In some examples, the position sensor 784 may include anencoder configured to provide a series of pulses to the control circuit760 as the I-beam 764 translates distally and proximally. The controlcircuit 760 may track the pulses to determine the position of the I-beam764. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theI-beam 764 by aggregating the number and direction of steps that themotor 754 has been instructed to execute. The position sensor 784 may belocated in the end effector 752 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 752 andadapted to operate with the surgical instrument 750 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 752. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe anvil 766 during a clamped condition. The strain gauge provides anelectrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe anvil 766 and the staple cartridge 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theanvil 766 and the staple cartridge 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theanvil 766 by a closure drive system. For example, one or more sensors788 can be at an interaction point between a closure tube and the anvil766 to detect the closure forces applied by a closure tube to the anvil766. The forces exerted on the anvil 766 can be representative of thetissue compression experienced by the tissue section captured betweenthe anvil 766 and the staple cartridge 768. The one or more sensors 788can be positioned at various interaction points along the closure drivesystem to detect the closure forces applied to the anvil 766 by theclosure drive system. The one or more sensors 788 may be sampled in realtime during a clamping operation by a processor of the control circuit760. The control circuit 760 receives real-time sample measurements toprovide and analyze time-based information and assess, in real time,closure forces applied to the anvil 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the I-beam 764 corresponds tothe current drawn by the motor 754. The force is converted to a digitalsignal and provided to the control circuit 760.

The control circuit 760 can be configured to simulate the response ofthe actual system of the instrument in the software of the controller. Adisplacement member can be actuated to move an I-beam 764 in the endeffector 752 at or near a target velocity. The surgical instrument 750can include a feedback controller, which can be one of any feedbackcontrollers, including, but not limited to a PID, a state feedback, LQR,and/or an adaptive controller, for example. The surgical instrument 750can include a power source to convert the signal from the feedbackcontroller into a physical input such as case voltage, PWM voltage,frequency modulated voltage, current, torque, and/or force, for example.

The actual drive system of the surgical instrument 750 is configured todrive the displacement member, cutting member, or I-beam 764, by abrushed DC motor with gearbox and mechanical links to an articulationand/or knife system. Another example is the electric motor 754 thatoperates the displacement member and the articulation driver, forexample, of an interchangeable shaft assembly. An outside influence isan unmeasured, unpredictable influence of things like tissue,surrounding bodies and friction on the physical system. Such outsideinfluence can be referred to as drag which acts in opposition to theelectric motor 754. The outside influence, such as drag, may cause theoperation of the physical system to deviate from a desired operation ofthe physical system.

Various example aspects are directed to a surgical instrument 750comprising an end effector 752 with motor-driven surgical stapling andcutting implements. For example, a motor 754 may drive a displacementmember distally and proximally along a longitudinal axis of the endeffector 752. The end effector 752 may comprise a pivotable anvil 766and, when configured for use, a staple cartridge 768 positioned oppositethe anvil 766. A clinician may grasp tissue between the anvil 766 andthe staple cartridge 768, as described herein. When ready to use theinstrument 750, the clinician may provide a firing signal, for exampleby depressing a trigger of the instrument 750. In response to the firingsignal, the motor 754 may drive the displacement member distally alongthe longitudinal axis of the end effector 752 from a proximal strokebegin position to a stroke end position distal of the stroke beginposition. As the displacement member translates distally, an I-beam 764with a cutting element positioned at a distal end, may cut the tissuebetween the staple cartridge 768 and the anvil 766.

In various examples, the surgical instrument 750 may comprise a controlcircuit 760 programmed to control the distal translation of thedisplacement member, such as the I-beam 764, for example, based on oneor more tissue conditions. The control circuit 760 may be programmed tosense tissue conditions, such as thickness, either directly orindirectly, as described herein. The control circuit 760 may beprogrammed to select a firing control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 760 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 760 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power.

In some examples, the control circuit 760 may initially operate themotor 754 in an open loop configuration for a first open loop portion ofa stroke of the displacement member. Based on a response of theinstrument 750 during the open loop portion of the stroke, the controlcircuit 760 may select a firing control program. The response of theinstrument may include, a translation distance of the displacementmember during the open loop portion, a time elapsed during the open loopportion, energy provided to the motor 754 during the open loop portion,a sum of pulse widths of a motor drive signal, etc. After the open loopportion, the control circuit 760 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during the closed loop portion of the stroke, the controlcircuit 760 may modulate the motor 754 based on translation datadescribing a position of the displacement member in a closed loop mannerto translate the displacement member at a constant velocity. Additionaldetails are disclosed in U.S. patent application Ser. No. 15/720,852,titled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICALINSTRUMENT, filed Sep. 29, 2017, which is herein incorporated byreference in its entirety.

FIG. 19 is a schematic diagram of a surgical instrument 790 configuredto control various functions according to one aspect of this disclosure.In one aspect, the surgical instrument 790 is programmed to controldistal translation of a displacement member such as the I-beam 764. Thesurgical instrument 790 comprises an end effector 792 that may comprisean anvil 766, an I-beam 764, and a removable staple cartridge 768 whichmay be interchanged with an RF cartridge 796 (shown in dashed line).

In one aspect, sensors 788 may be implemented as a limit switch,electromechanical device, solid-state switches, Hall-effect devices, MRdevices, GMR devices, magnetometers, among others. In otherimplementations, the sensors 638 may be solid-state switches thatoperate under the influence of light, such as optical sensors, IRsensors, ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors788 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the position sensor 784 may be implemented as an absolutepositioning system comprising a magnetic rotary absolute positioningsystem implemented as an AS5055EQFT single-chip magnetic rotary positionsensor available from Austria Microsystems, AG. The position sensor 784may interface with the control circuit 760 to provide an absolutepositioning system. The position may include multiple Hall-effectelements located above a magnet and coupled to a CORDIC processor, alsoknown as the digit-by-digit method and Volder's algorithm, that isprovided to implement a simple and efficient algorithm to calculatehyperbolic and trigonometric functions that require only addition,subtraction, bitshift, and table lookup operations.

In one aspect, the I-beam 764 may be implemented as a knife membercomprising a knife body that operably supports a tissue cutting bladethereon and may further include anvil engagement tabs or features andchannel engagement features or a foot. In one aspect, the staplecartridge 768 may be implemented as a standard (mechanical) surgicalfastener cartridge. In one aspect, the RF cartridge 796 may beimplemented as an RF cartridge. These and other sensors arrangements aredescribed in commonly owned U.S. patent application Ser. No. 15/628,175,titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICALSTAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, which is hereinincorporated by reference in its entirety.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the I-beam 764, can be measured by anabsolute positioning system, sensor arrangement, and position sensorrepresented as position sensor 784. Because the I-beam 764 is coupled tothe longitudinally movable drive member, the position of the I-beam 764can be determined by measuring the position of the longitudinallymovable drive member employing the position sensor 784. Accordingly, inthe following description, the position, displacement, and/ortranslation of the I-beam 764 can be achieved by the position sensor 784as described herein. A control circuit 760 may be programmed to controlthe translation of the displacement member, such as the I-beam 764, asdescribed herein. The control circuit 760, in some examples, maycomprise one or more microcontrollers, microprocessors, or othersuitable processors for executing instructions that cause the processoror processors to control the displacement member, e.g., the I-beam 764,in the manner described. In one aspect, a timer/counter 781 provides anoutput signal, such as the elapsed time or a digital count, to thecontrol circuit 760 to correlate the position of the I-beam 764 asdetermined by the position sensor 784 with the output of thetimer/counter 781 such that the control circuit 760 can determine theposition of the I-beam 764 at a specific time (t) relative to a startingposition. The timer/counter 781 may be configured to measure elapsedtime, count external events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theI-beam 764 via a transmission 756. The transmission 756 may include oneor more gears or other linkage components to couple the motor 754 to theI-beam 764. A position sensor 784 may sense a position of the I-beam764. The position sensor 784 may be or include any type of sensor thatis capable of generating position data that indicate a position of theI-beam 764. In some examples, the position sensor 784 may include anencoder configured to provide a series of pulses to the control circuit760 as the I-beam 764 translates distally and proximally. The controlcircuit 760 may track the pulses to determine the position of the I-beam764. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theI-beam 764 by aggregating the number and direction of steps that themotor has been instructed to execute. The position sensor 784 may belocated in the end effector 792 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 792 andadapted to operate with the surgical instrument 790 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 792. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe anvil 766 during a clamped condition. The strain gauge provides anelectrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe anvil 766 and the staple cartridge 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theanvil 766 and the staple cartridge 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theanvil 766 by the closure drive system. For example, one or more sensors788 can be at an interaction point between a closure tube and the anvil766 to detect the closure forces applied by a closure tube to the anvil766. The forces exerted on the anvil 766 can be representative of thetissue compression experienced by the tissue section captured betweenthe anvil 766 and the staple cartridge 768. The one or more sensors 788can be positioned at various interaction points along the closure drivesystem to detect the closure forces applied to the anvil 766 by theclosure drive system. The one or more sensors 788 may be sampled in realtime during a clamping operation by a processor portion of the controlcircuit 760. The control circuit 760 receives real-time samplemeasurements to provide and analyze time-based information and assess,in real time, closure forces applied to the anvil 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the I-beam 764 corresponds tothe current drawn by the motor 754. The force is converted to a digitalsignal and provided to the control circuit 760.

An RF energy source 794 is coupled to the end effector 792 and isapplied to the RF cartridge 796 when the RF cartridge 796 is loaded inthe end effector 792 in place of the staple cartridge 768. The controlcircuit 760 controls the delivery of the RF energy to the RF cartridge796.

Additional details are disclosed in U.S. patent application Ser. No.15/636,096, titled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE ANDRADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, filed Jun. 28,2017, which is herein incorporated by reference in its entirety.

Generator Hardware

FIG. 20 is a simplified block diagram of a generator 800 configured toprovide inductorless tuning, among other benefits. Additional details ofthe generator 800 are described in U.S. Pat. No. 9,060,775, titledSURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES, whichissued on Jun. 23, 2015, which is herein incorporated by reference inits entirety. The generator 800 may comprise a patient isolated stage802 in communication with a non-isolated stage 804 via a powertransformer 806. A secondary winding 808 of the power transformer 806 iscontained in the isolated stage 802 and may comprise a tappedconfiguration (e.g., a center-tapped or a non-center-tappedconfiguration) to define drive signal outputs 810 a, 810 b, 810 c fordelivering drive signals to different surgical instruments, such as, forexample, an ultrasonic surgical instrument, an RF electrosurgicalinstrument, and a multifunction surgical instrument which includesultrasonic and RF energy modes that can be delivered alone orsimultaneously. In particular, drive signal outputs 810 a, 810 c mayoutput an ultrasonic drive signal (e.g., a 420V root-mean-square (RMS)drive signal) to an ultrasonic surgical instrument, and drive signaloutputs 810 b, 810 c may output an RF electrosurgical drive signal(e.g., a 100V RMS drive signal) to an RF electrosurgical instrument,with the drive signal output 810 b corresponding to the center tap ofthe power transformer 806.

In certain forms, the ultrasonic and electrosurgical drive signals maybe provided simultaneously to distinct surgical instruments and/or to asingle surgical instrument, such as the multifunction surgicalinstrument, having the capability to deliver both ultrasonic andelectrosurgical energy to tissue. It will be appreciated that theelectrosurgical signal, provided either to a dedicated electrosurgicalinstrument and/or to a combined multifunction ultrasonic/electrosurgicalinstrument may be either a therapeutic or sub-therapeutic level signalwhere the sub-therapeutic signal can be used, for example, to monitortissue or instrument conditions and provide feedback to the generator.For example, the ultrasonic and RF signals can be delivered separatelyor simultaneously from a generator with a single output port in order toprovide the desired output signal to the surgical instrument, as will bediscussed in more detail below. Accordingly, the generator can combinethe ultrasonic and electrosurgical RF energies and deliver the combinedenergies to the multifunction ultrasonic/electrosurgical instrument.Bipolar electrodes can be placed on one or both jaws of the endeffector. One jaw may be driven by ultrasonic energy in addition toelectrosurgical RF energy, working simultaneously. The ultrasonic energymay be employed to dissect tissue, while the electrosurgical RF energymay be employed for vessel sealing.

The non-isolated stage 804 may comprise a power amplifier 812 having anoutput connected to a primary winding 814 of the power transformer 806.In certain forms, the power amplifier 812 may comprise a push-pullamplifier. For example, the non-isolated stage 804 may further comprisea logic device 816 for supplying a digital output to a digital-to-analogconverter (DAC) circuit 818, which in turn supplies a correspondinganalog signal to an input of the power amplifier 812. In certain forms,the logic device 816 may comprise a programmable gate array (PGA), aFPGA, programmable logic device (PLD), among other logic circuits, forexample. The logic device 816, by virtue of controlling the input of thepower amplifier 812 via the DAC circuit 818, may therefore control anyof a number of parameters (e.g., frequency, waveform shape, waveformamplitude) of drive signals appearing at the drive signal outputs 810 a,810 b, 810 c. In certain forms and as discussed below, the logic device816, in conjunction with a processor (e.g., a DSP discussed below), mayimplement a number of DSP-based and/or other control algorithms tocontrol parameters of the drive signals output by the generator 800.

Power may be supplied to a power rail of the power amplifier 812 by aswitch-mode regulator 820, e.g., a power converter. In certain forms,the switch-mode regulator 820 may comprise an adjustable buck regulator,for example. The non-isolated stage 804 may further comprise a firstprocessor 822, which in one form may comprise a DSP processor such as anAnalog Devices ADSP-21469 SHARC DSP, available from Analog Devices,Norwood, Mass., for example, although in various forms any suitableprocessor may be employed. In certain forms the DSP processor 822 maycontrol the operation of the switch-mode regulator 820 responsive tovoltage feedback data received from the power amplifier 812 by the DSPprocessor 822 via an ADC circuit 824. In one form, for example, the DSPprocessor 822 may receive as input, via the ADC circuit 824, thewaveform envelope of a signal (e.g., an RF signal) being amplified bythe power amplifier 812. The DSP processor 822 may then control theswitch-mode regulator 820 (e.g., via a PWM output) such that the railvoltage supplied to the power amplifier 812 tracks the waveform envelopeof the amplified signal. By dynamically modulating the rail voltage ofthe power amplifier 812 based on the waveform envelope, the efficiencyof the power amplifier 812 may be significantly improved relative to afixed rail voltage amplifier schemes.

In certain forms, the logic device 816, in conjunction with the DSPprocessor 822, may implement a digital synthesis circuit such as adirect digital synthesizer control scheme to control the waveform shape,frequency, and/or amplitude of drive signals output by the generator800. In one form, for example, the logic device 816 may implement a DDScontrol algorithm by recalling waveform samples stored in a dynamicallyupdated lookup table (LUT), such as a RAM LUT, which may be embedded inan FPGA. This control algorithm is particularly useful for ultrasonicapplications in which an ultrasonic transducer, such as an ultrasonictransducer, may be driven by a clean sinusoidal current at its resonantfrequency. Because other frequencies may excite parasitic resonances,minimizing or reducing the total distortion of the motional branchcurrent may correspondingly minimize or reduce undesirable resonanceeffects. Because the waveform shape of a drive signal output by thegenerator 800 is impacted by various sources of distortion present inthe output drive circuit (e.g., the power transformer 806, the poweramplifier 812), voltage and current feedback data based on the drivesignal may be input into an algorithm, such as an error controlalgorithm implemented by the DSP processor 822, which compensates fordistortion by suitably pre-distorting or modifying the waveform samplesstored in the LUT on a dynamic, ongoing basis (e.g., in real time). Inone form, the amount or degree of pre-distortion applied to the LUTsamples may be based on the error between a computed motional branchcurrent and a desired current waveform shape, with the error beingdetermined on a sample-by-sample basis. In this way, the pre-distortedLUT samples, when processed through the drive circuit, may result in amotional branch drive signal having the desired waveform shape (e.g.,sinusoidal) for optimally driving the ultrasonic transducer. In suchforms, the LUT waveform samples will therefore not represent the desiredwaveform shape of the drive signal, but rather the waveform shape thatis required to ultimately produce the desired waveform shape of themotional branch drive signal when distortion effects are taken intoaccount.

The non-isolated stage 804 may further comprise a first ADC circuit 826and a second ADC circuit 828 coupled to the output of the powertransformer 806 via respective isolation transformers 830, 832 forrespectively sampling the voltage and current of drive signals output bythe generator 800. In certain forms, the ADC circuits 826, 828 may beconfigured to sample at high speeds (e.g., 80 mega samples per second(MSPS)) to enable oversampling of the drive signals. In one form, forexample, the sampling speed of the ADC circuits 826, 828 may enableapproximately 200× (depending on frequency) oversampling of the drivesignals. In certain forms, the sampling operations of the ADC circuit826, 828 may be performed by a single ADC circuit receiving inputvoltage and current signals via a two-way multiplexer. The use ofhigh-speed sampling in forms of the generator 800 may enable, amongother things, calculation of the complex current flowing through themotional branch (which may be used in certain forms to implementDDS-based waveform shape control described above), accurate digitalfiltering of the sampled signals, and calculation of real powerconsumption with a high degree of precision. Voltage and currentfeedback data output by the ADC circuits 826, 828 may be received andprocessed (e.g., first-in-first-out (FIFO) buffer, multiplexer) by thelogic device 816 and stored in data memory for subsequent retrieval by,for example, the DSP processor 822. As noted above, voltage and currentfeedback data may be used as input to an algorithm for pre-distorting ormodifying LUT waveform samples on a dynamic and ongoing basis. Incertain forms, this may require each stored voltage and current feedbackdata pair to be indexed based on, or otherwise associated with, acorresponding LUT sample that was output by the logic device 816 whenthe voltage and current feedback data pair was acquired. Synchronizationof the LUT samples and the voltage and current feedback data in thismanner contributes to the correct timing and stability of thepre-distortion algorithm.

In certain forms, the voltage and current feedback data may be used tocontrol the frequency and/or amplitude (e.g., current amplitude) of thedrive signals. In one form, for example, voltage and current feedbackdata may be used to determine impedance phase. The frequency of thedrive signal may then be controlled to minimize or reduce the differencebetween the determined impedance phase and an impedance phase setpoint(e.g., 0°), thereby minimizing or reducing the effects of harmonicdistortion and correspondingly enhancing impedance phase measurementaccuracy. The determination of phase impedance and a frequency controlsignal may be implemented in the DSP processor 822, for example, withthe frequency control signal being supplied as input to a DDS controlalgorithm implemented by the logic device 816.

In another form, for example, the current feedback data may be monitoredin order to maintain the current amplitude of the drive signal at acurrent amplitude setpoint. The current amplitude setpoint may bespecified directly or determined indirectly based on specified voltageamplitude and power setpoints. In certain forms, control of the currentamplitude may be implemented by control algorithm, such as, for example,a proportional-integral-derivative (PID) control algorithm, in the DSPprocessor 822. Variables controlled by the control algorithm to suitablycontrol the current amplitude of the drive signal may include, forexample, the scaling of the LUT waveform samples stored in the logicdevice 816 and/or the full-scale output voltage of the DAC circuit 818(which supplies the input to the power amplifier 812) via a DAC circuit834.

The non-isolated stage 804 may further comprise a second processor 836for providing, among other things user interface (UI) functionality. Inone form, the UI processor 836 may comprise an Atmel AT91SAM9263processor having an ARM 926EJ-S core, available from Atmel Corporation,San Jose, Calif., for example. Examples of UI functionality supported bythe UI processor 836 may include audible and visual user feedback,communication with peripheral devices (e.g., via a USB interface),communication with a foot switch, communication with an input device(e.g., a touch screen display) and communication with an output device(e.g., a speaker). The UI processor 836 may communicate with the DSPprocessor 822 and the logic device 816 (e.g., via SPI buses). Althoughthe UI processor 836 may primarily support UI functionality, it may alsocoordinate with the DSP processor 822 to implement hazard mitigation incertain forms. For example, the UI processor 836 may be programmed tomonitor various aspects of user input and/or other inputs (e.g., touchscreen inputs, foot switch inputs, temperature sensor inputs) and maydisable the drive output of the generator 800 when an erroneouscondition is detected.

In certain forms, both the DSP processor 822 and the UI processor 836,for example, may determine and monitor the operating state of thegenerator 800. For the DSP processor 822, the operating state of thegenerator 800 may dictate, for example, which control and/or diagnosticprocesses are implemented by the DSP processor 822. For the UI processor836, the operating state of the generator 800 may dictate, for example,which elements of a UI (e.g., display screens, sounds) are presented toa user. The respective DSP and UI processors 822, 836 may independentlymaintain the current operating state of the generator 800 and recognizeand evaluate possible transitions out of the current operating state.The DSP processor 822 may function as the master in this relationshipand determine when transitions between operating states are to occur.The UI processor 836 may be aware of valid transitions between operatingstates and may confirm if a particular transition is appropriate. Forexample, when the DSP processor 822 instructs the UI processor 836 totransition to a specific state, the UI processor 836 may verify thatrequested transition is valid. In the event that a requested transitionbetween states is determined to be invalid by the UI processor 836, theUI processor 836 may cause the generator 800 to enter a failure mode.

The non-isolated stage 804 may further comprise a controller 838 formonitoring input devices (e.g., a capacitive touch sensor used forturning the generator 800 on and off, a capacitive touch screen). Incertain forms, the controller 838 may comprise at least one processorand/or other controller device in communication with the UI processor836. In one form, for example, the controller 838 may comprise aprocessor (e.g., a Meg168 8-bit controller available from Atmel)configured to monitor user input provided via one or more capacitivetouch sensors. In one form, the controller 838 may comprise a touchscreen controller (e.g., a QT5480 touch screen controller available fromAtmel) to control and manage the acquisition of touch data from acapacitive touch screen.

In certain forms, when the generator 800 is in a “power off” state, thecontroller 838 may continue to receive operating power (e.g., via a linefrom a power supply of the generator 800, such as the power supply 854discussed below). In this way, the controller 838 may continue tomonitor an input device (e.g., a capacitive touch sensor located on afront panel of the generator 800) for turning the generator 800 on andoff. When the generator 800 is in the power off state, the controller838 may wake the power supply (e.g., enable operation of one or moreDC/DC voltage converters 856 of the power supply 854) if activation ofthe “on/off” input device by a user is detected. The controller 838 maytherefore initiate a sequence for transitioning the generator 800 to a“power on” state. Conversely, the controller 838 may initiate a sequencefor transitioning the generator 800 to the power off state if activationof the “on/off” input device is detected when the generator 800 is inthe power on state. In certain forms, for example, the controller 838may report activation of the “on/off” input device to the UI processor836, which in turn implements the necessary process sequence fortransitioning the generator 800 to the power off state. In such forms,the controller 838 may have no independent ability for causing theremoval of power from the generator 800 after its power on state hasbeen established.

In certain forms, the controller 838 may cause the generator 800 toprovide audible or other sensory feedback for alerting the user that apower on or power off sequence has been initiated. Such an alert may beprovided at the beginning of a power on or power off sequence and priorto the commencement of other processes associated with the sequence.

In certain forms, the isolated stage 802 may comprise an instrumentinterface circuit 840 to, for example, provide a communication interfacebetween a control circuit of a surgical instrument (e.g., a controlcircuit comprising handpiece switches) and components of thenon-isolated stage 804, such as, for example, the logic device 816, theDSP processor 822, and/or the UI processor 836. The instrument interfacecircuit 840 may exchange information with components of the non-isolatedstage 804 via a communication link that maintains a suitable degree ofelectrical isolation between the isolated and non-isolated stages 802,804, such as, for example, an IR-based communication link. Power may besupplied to the instrument interface circuit 840 using, for example, alow-dropout voltage regulator powered by an isolation transformer drivenfrom the non-isolated stage 804.

In one form, the instrument interface circuit 840 may comprise a logiccircuit 842 (e.g., logic circuit, programmable logic circuit, PGA, FPGA,PLD) in communication with a signal conditioning circuit 844. The signalconditioning circuit 844 may be configured to receive a periodic signalfrom the logic circuit 842 (e.g., a 2 kHz square wave) to generate abipolar interrogation signal having an identical frequency. Theinterrogation signal may be generated, for example, using a bipolarcurrent source fed by a differential amplifier. The interrogation signalmay be communicated to a surgical instrument control circuit (e.g., byusing a conductive pair in a cable that connects the generator 800 tothe surgical instrument) and monitored to determine a state orconfiguration of the control circuit. The control circuit may comprise anumber of switches, resistors, and/or diodes to modify one or morecharacteristics (e.g., amplitude, rectification) of the interrogationsignal such that a state or configuration of the control circuit isuniquely discernable based on the one or more characteristics. In oneform, for example, the signal conditioning circuit 844 may comprise anADC circuit for generating samples of a voltage signal appearing acrossinputs of the control circuit resulting from passage of interrogationsignal therethrough. The logic circuit 842 (or a component of thenon-isolated stage 804) may then determine the state or configuration ofthe control circuit based on the ADC circuit samples.

In one form, the instrument interface circuit 840 may comprise a firstdata circuit interface 846 to enable information exchange between thelogic circuit 842 (or other element of the instrument interface circuit840) and a first data circuit disposed in or otherwise associated with asurgical instrument. In certain forms, for example, a first data circuitmay be disposed in a cable integrally attached to a surgical instrumenthandpiece or in an adaptor for interfacing a specific surgicalinstrument type or model with the generator 800. The first data circuitmay be implemented in any suitable manner and may communicate with thegenerator according to any suitable protocol, including, for example, asdescribed herein with respect to the first data circuit. In certainforms, the first data circuit may comprise a non-volatile storagedevice, such as an EEPROM device. In certain forms, the first datacircuit interface 846 may be implemented separately from the logiccircuit 842 and comprise suitable circuitry (e.g., discrete logicdevices, a processor) to enable communication between the logic circuit842 and the first data circuit. In other forms, the first data circuitinterface 846 may be integral with the logic circuit 842.

In certain forms, the first data circuit may store informationpertaining to the particular surgical instrument with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical instrumenthas been used, and/or any other type of information. This informationmay be read by the instrument interface circuit 840 (e.g., by the logiccircuit 842), transferred to a component of the non-isolated stage 804(e.g., to logic device 816, DSP processor 822, and/or UI processor 836)for presentation to a user via an output device and/or for controlling afunction or operation of the generator 800. Additionally, any type ofinformation may be communicated to the first data circuit for storagetherein via the first data circuit interface 846 (e.g., using the logiccircuit 842). Such information may comprise, for example, an updatednumber of operations in which the surgical instrument has been usedand/or dates and/or times of its usage.

As discussed previously, a surgical instrument may be detachable from ahandpiece (e.g., the multifunction surgical instrument may be detachablefrom the handpiece) to promote instrument interchangeability and/ordisposability. In such cases, conventional generators may be limited intheir ability to recognize particular instrument configurations beingused and to optimize control and diagnostic processes accordingly. Theaddition of readable data circuits to surgical instruments to addressthis issue is problematic from a compatibility standpoint, however. Forexample, designing a surgical instrument to remain backwardly compatiblewith generators that lack the requisite data reading functionality maybe impractical due to, for example, differing signal schemes, designcomplexity, and cost. Forms of instruments discussed herein addressthese concerns by using data circuits that may be implemented inexisting surgical instruments economically and with minimal designchanges to preserve compatibility of the surgical instruments withcurrent generator platforms.

Additionally, forms of the generator 800 may enable communication withinstrument-based data circuits. For example, the generator 800 may beconfigured to communicate with a second data circuit contained in aninstrument (e.g., the multifunction surgical instrument). In some forms,the second data circuit may be implemented in a many similar to that ofthe first data circuit described herein. The instrument interfacecircuit 840 may comprise a second data circuit interface 848 to enablethis communication. In one form, the second data circuit interface 848may comprise a tri-state digital interface, although other interfacesmay also be used. In certain forms, the second data circuit maygenerally be any circuit for transmitting and/or receiving data. In oneform, for example, the second data circuit may store informationpertaining to the particular surgical instrument with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical instrumenthas been used, and/or any other type of information.

In some forms, the second data circuit may store information about theelectrical and/or ultrasonic properties of an associated ultrasonictransducer, end effector, or ultrasonic drive system. For example, thefirst data circuit may indicate a burn-in frequency slope, as describedherein. Additionally or alternatively, any type of information may becommunicated to second data circuit for storage therein via the seconddata circuit interface 848 (e.g., using the logic circuit 842). Suchinformation may comprise, for example, an updated number of operationsin which the instrument has been used and/or dates and/or times of itsusage. In certain forms, the second data circuit may transmit dataacquired by one or more sensors (e.g., an instrument-based temperaturesensor). In certain forms, the second data circuit may receive data fromthe generator 800 and provide an indication to a user (e.g., a lightemitting diode indication or other visible indication) based on thereceived data.

In certain forms, the second data circuit and the second data circuitinterface 848 may be configured such that communication between thelogic circuit 842 and the second data circuit can be effected withoutthe need to provide additional conductors for this purpose (e.g.,dedicated conductors of a cable connecting a handpiece to the generator800). In one form, for example, information may be communicated to andfrom the second data circuit using a one-wire bus communication schemeimplemented on existing cabling, such as one of the conductors usedtransmit interrogation signals from the signal conditioning circuit 844to a control circuit in a handpiece. In this way, design changes ormodifications to the surgical instrument that might otherwise benecessary are minimized or reduced. Moreover, because different types ofcommunications implemented over a common physical channel can befrequency-band separated, the presence of a second data circuit may be“invisible” to generators that do not have the requisite data readingfunctionality, thus enabling backward compatibility of the surgicalinstrument.

In certain forms, the isolated stage 802 may comprise at least oneblocking capacitor 850-1 connected to the drive signal output 810 b toprevent passage of DC current to a patient. A single blocking capacitormay be required to comply with medical regulations or standards, forexample. While failure in single-capacitor designs is relativelyuncommon, such failure may nonetheless have negative consequences. Inone form, a second blocking capacitor 850-2 may be provided in serieswith the blocking capacitor 850-1, with current leakage from a pointbetween the blocking capacitors 850-1, 850-2 being monitored by, forexample, an ADC circuit 852 for sampling a voltage induced by leakagecurrent. The samples may be received by the logic circuit 842, forexample. Based changes in the leakage current (as indicated by thevoltage samples), the generator 800 may determine when at least one ofthe blocking capacitors 850-1, 850-2 has failed, thus providing abenefit over single-capacitor designs having a single point of failure.

In certain forms, the non-isolated stage 804 may comprise a power supply854 for delivering DC power at a suitable voltage and current. The powersupply may comprise, for example, a 400 W power supply for delivering a48 VDC system voltage. The power supply 854 may further comprise one ormore DC/DC voltage converters 856 for receiving the output of the powersupply to generate DC outputs at the voltages and currents required bythe various components of the generator 800. As discussed above inconnection with the controller 838, one or more of the DC/DC voltageconverters 856 may receive an input from the controller 838 whenactivation of the “on/off” input device by a user is detected by thecontroller 838 to enable operation of, or wake, the DC/DC voltageconverters 856.

FIG. 21 illustrates an example of a generator 900, which is one form ofthe generator 800 (FIG. 20). The generator 900 is configured to delivermultiple energy modalities to a surgical instrument. The generator 900provides RF and ultrasonic signals for delivering energy to a surgicalinstrument either independently or simultaneously. The RF and ultrasonicsignals may be provided alone or in combination and may be providedsimultaneously. As noted above, at least one generator output candeliver multiple energy modalities (e.g., ultrasonic, bipolar ormonopolar RF, irreversible and/or reversible electroporation, and/ormicrowave energy, among others) through a single port, and these signalscan be delivered separately or simultaneously to the end effector totreat tissue. The generator 900 comprises a processor 902 coupled to awaveform generator 904. The processor 902 and waveform generator 904 areconfigured to generate a variety of signal waveforms based oninformation stored in a memory coupled to the processor 902, not shownfor clarity of disclosure. The digital information associated with awaveform is provided to the waveform generator 904 which includes one ormore DAC circuits to convert the digital input into an analog output.The analog output is fed to an amplifier 1106 for signal conditioningand amplification. The conditioned and amplified output of the amplifier906 is coupled to a power transformer 908. The signals are coupledacross the power transformer 908 to the secondary side, which is in thepatient isolation side. A first signal of a first energy modality isprovided to the surgical instrument between the terminals labeledENERGY1 and RETURN. A second signal of a second energy modality iscoupled across a capacitor 910 and is provided to the surgicalinstrument between the terminals labeled ENERGY2 and RETURN. It will beappreciated that more than two energy modalities may be output and thusthe subscript “n” may be used to designate that up to n ENERGYnterminals may be provided, where n is a positive integer greater than 1.It also will be appreciated that up to “n” return paths RETURNn may beprovided without departing from the scope of the present disclosure.

A first voltage sensing circuit 912 is coupled across the terminalslabeled ENERGY1 and the RETURN path to measure the output voltagetherebetween. A second voltage sensing circuit 924 is coupled across theterminals labeled ENERGY2 and the RETURN path to measure the outputvoltage therebetween. A current sensing circuit 914 is disposed inseries with the RETURN leg of the secondary side of the powertransformer 908 as shown to measure the output current for either energymodality. If different return paths are provided for each energymodality, then a separate current sensing circuit should be provided ineach return leg. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to respective isolation transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 918. The outputs of the isolationtransformers 916, 928, 922 in the on the primary side of the powertransformer 908 (non-patient isolated side) are provided to a one ormore ADC circuit 926. The digitized output of the ADC circuit 926 isprovided to the processor 902 for further processing and computation.The output voltages and output current feedback information can beemployed to adjust the output voltage and current provided to thesurgical instrument and to compute output impedance, among otherparameters. Input/output communications between the processor 902 andpatient isolated circuits is provided through an interface circuit 920.Sensors also may be in electrical communication with the processor 902by way of the interface circuit 920.

In one aspect, the impedance may be determined by the processor 902 bydividing the output of either the first voltage sensing circuit 912coupled across the terminals labeled ENERGY1/RETURN or the secondvoltage sensing circuit 924 coupled across the terminals labeledENERGY2/RETURN by the output of the current sensing circuit 914 disposedin series with the RETURN leg of the secondary side of the powertransformer 908. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to separate isolations transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 916. The digitized voltage and currentsensing measurements from the ADC circuit 926 are provided the processor902 for computing impedance. As an example, the first energy modalityENERGY1 may be ultrasonic energy and the second energy modality ENERGY2may be RF energy. Nevertheless, in addition to ultrasonic and bipolar ormonopolar RF energy modalities, other energy modalities includeirreversible and/or reversible electroporation and/or microwave energy,among others. Also, although the example illustrated in FIG. 21 shows asingle return path RETURN may be provided for two or more energymodalities, in other aspects, multiple return paths RETURNn may beprovided for each energy modality ENERGYn. Thus, as described herein,the ultrasonic transducer impedance may be measured by dividing theoutput of the first voltage sensing circuit 912 by the current sensingcircuit 914 and the tissue impedance may be measured by dividing theoutput of the second voltage sensing circuit 924 by the current sensingcircuit 914.

As shown in FIG. 21, the generator 900 comprising at least one outputport can include a power transformer 908 with a single output and withmultiple taps to provide power in the form of one or more energymodalities, such as ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers, for example, to the end effector depending on the type oftreatment of tissue being performed. For example, the generator 900 candeliver energy with higher voltage and lower current to drive anultrasonic transducer, with lower voltage and higher current to drive RFelectrodes for sealing tissue, or with a coagulation waveform for spotcoagulation using either monopolar or bipolar RF electrosurgicalelectrodes. The output waveform from the generator 900 can be steered,switched, or filtered to provide the frequency to the end effector ofthe surgical instrument. The connection of an ultrasonic transducer tothe generator 900 output would be preferably located between the outputlabeled ENERGY1 and RETURN as shown in FIG. 21. In one example, aconnection of RF bipolar electrodes to the generator 900 output would bepreferably located between the output labeled ENERGY2 and RETURN. In thecase of monopolar output, the preferred connections would be activeelectrode (e.g., pencil or other probe) to the ENERGY2 output and asuitable return pad connected to the RETURN output.

Additional details are disclosed in U.S. Patent Application PublicationNo. 2017/0086914, titled TECHNIQUES FOR OPERATING GENERATOR FORDIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS, which published on Mar. 30, 2017, which is hereinincorporated by reference in its entirety.

As used throughout this description, the term “wireless” and itsderivatives may be used to describe circuits, devices, systems, methods,techniques, communications channels, etc., that may communicate datathrough the use of modulated electromagnetic radiation through anon-solid medium. The term does not imply that the associated devices donot contain any wires, although in some aspects they might not. Thecommunication module may implement any of a number of wireless or wiredcommunication standards or protocols, including but not limited to W-Fi(IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long termevolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA,TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as anyother wireless and wired protocols that are designated as 3G, 4G, 5G,and beyond. The computing module may include a plurality ofcommunication modules. For instance, a first communication module may bededicated to shorter range wireless communications such as Wi-Fi andBluetooth and a second communication module may be dedicated to longerrange wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE,Ev-DO, and others.

As used herein a processor or processing unit is an electronic circuitwhich performs operations on some external data source, usually memoryor some other data stream. The term is used herein to refer to thecentral processor (central processing unit) in a system or computersystems (especially systems on a chip (SoCs)) that combine a number ofspecialized “processors.”

As used herein, a system on a chip or system on chip (SoC or SOC) is anintegrated circuit (also known as an “IC” or “chip”) that integrates allcomponents of a computer or other electronic systems. It may containdigital, analog, mixed-signal, and often radio-frequency functions—allon a single substrate. A SoC integrates a microcontroller (ormicroprocessor) with advanced peripherals like graphics processing unit(GPU), Wi-Fi module, or coprocessor. A SoC may or may not containbuilt-in memory.

As used herein, a microcontroller or controller is a system thatintegrates a microprocessor with peripheral circuits and memory. Amicrocontroller (or MCU for microcontroller unit) may be implemented asa small computer on a single integrated circuit. It may be similar to aSoC; an SoC may include a microcontroller as one of its components. Amicrocontroller may contain one or more core processing units (CPUs)along with memory and programmable input/output peripherals. Programmemory in the form of Ferroelectric RAM, NOR flash or OTP ROM is alsooften included on chip, as well as a small amount of RAM.Microcontrollers may be employed for embedded applications, in contrastto the microprocessors used in personal computers or other generalpurpose applications consisting of various discrete chips.

As used herein, the term controller or microcontroller may be astand-alone IC or chip device that interfaces with a peripheral device.This may be a link between two parts of a computer or a controller on anexternal device that manages the operation of (and connection with) thatdevice.

Any of the processors or microcontrollers described herein, may beimplemented by any single core or multicore processor such as thoseknown under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising on-chipmemory of 256 KB single-cycle flash memory, or other non-volatilememory, up to 40 MHz, a prefetch buffer to improve performance above 40MHz, a 32 KB single-cycle serial random access memory (SRAM), internalread-only memory (ROM) loaded with StellarisWare® software, 2 KBelectrically erasable programmable read-only memory (EEPROM), one ormore pulse width modulation (PWM) modules, one or more quadratureencoder inputs (QEI) analog, one or more 12-bit Analog-to-DigitalConverters (ADC) with 12 analog input channels, details of which areavailable for the product datasheet.

In one aspect, the processor may comprise a safety controller comprisingtwo controller-based families such as TMS570 and RM4x known under thetrade name Hercules ARM Cortex R4, also by Texas Instruments. The safetycontroller may be configured specifically for IEC 61508 and ISO 26262safety critical applications, among others, to provide advancedintegrated safety features while delivering scalable performance,connectivity, and memory options.

Modular devices include the modules (as described in connection withFIGS. 3 and 9, for example) that are receivable within a surgical huband the surgical devices or instruments that can be connected to thevarious modules in order to connect or pair with the correspondingsurgical hub. The modular devices include, for example, intelligentsurgical instruments, medical imaging devices, suction/irrigationdevices, smoke evacuators, energy generators, ventilators, insufflators,and displays. The modular devices described herein can be controlled bycontrol algorithms. The control algorithms can be executed on themodular device itself, on the surgical hub to which the particularmodular device is paired, or on both the modular device and the surgicalhub (e.g., via a distributed computing architecture). In someexemplifications, the modular devices' control algorithms control thedevices based on data sensed by the modular device itself (i.e., bysensors in, on, or connected to the modular device). This data can berelated to the patient being operated on (e.g., tissue properties orinsufflation pressure) or the modular device itself (e.g., the rate atwhich a knife is being advanced, motor current, or energy levels). Forexample, a control algorithm for a surgical stapling and cuttinginstrument can control the rate at which the instrument's motor drivesits knife through tissue according to resistance encountered by theknife as it advances.

Long Distance Communication and Condition Handling of Devices and Data

Surgical procedures are performed by different surgeons at differentlocations, some with much less experience than others. For a givensurgical procedure, there are many parameters that can be varied toattempt to realize a desired outcome. For example, for a given surgicalprocedure which utilizes energy supplied by a generator, the surgeonoften relies on experience alone for determining which mode of energy toutilize, which level of output power to utilize, the duration of theapplication of the energy, etc., in order to attempt to realize thedesired outcome. To increase the likelihood of realizing desiredoutcomes for a plurality of different surgical procedures, each surgeonshould be provided with best practice recommendations which are based onimportant relationships identified within large, accurate data sets ofinformation associated with multiple surgical procedures performed inmultiple locations over time. However, there are many ways that suchdata sets can be rendered compromised, inaccurate, and/or unsecure,thereby calling into question the applicability of the best practicerecommendations derived therefrom. For example, for data sent from asource to a cloud-based system, the data can be lost while in transit tothe cloud-based system, the data can be corrupted while in transit tothe cloud-based system, the confidentiality of the data can be comprisedwhile in transit to the cloud-based system, and/or the content of thedata can be altered while in transit to the cloud-based system.

A plurality of operating rooms located in multiple locations can each beequipped with a surgical hub. When a given surgical procedure isperformed in a given operating room, the surgical hub can receive dataassociated with the surgical procedure and communicate the data to acloud-based system. Over time, the cloud-based system will receive largedata sets of information associated with the surgeries. The data can becommunicated from the surgical hubs to the cloud-based system in amanner which allows for the cloud-based system to (1) verify theauthenticity of the communicated data, (2) authenticate each of therespective surgical hubs which communicated the data, and (3) trace thepaths the data followed from the respective surgical hubs to thecloud-based system.

Accordingly, in one aspect, the present disclosure provides a surgicalhub for transmitting generator data associated with a surgical procedureto a cloud-based system communicatively coupled to a plurality ofsurgical hubs. The surgical hub comprises a processor and a memorycoupled to the processor. The memory stores instructions executable bythe processor to receive data from a generator, encrypt the data,generate a message authentication code (MAC) based on the data, generatea datagram comprising the encrypted data, the generated MAC, a sourceidentifier, and a destination identifier, and transmit the datagram to acloud-based system. The data is structured into a data packet comprisingat least two of the following fields: a field that indicates the sourceof the data, a unique time stamp, a field indicating an energy mode ofthe generator, a field indicating the power output of the generator, anda field indicating a duration of the power output of the generator. Thedatagram allows for the cloud-based system to decrypt the encrypted dataof the transmitted datagram, verify integrity of the data based on theMAC, authenticate the surgical hub as the source of the datagram, andvalidate a transmission path followed by the datagram between thesurgical hub and the cloud-based system.

In various aspects, the present disclosure provides a control circuit totransmit generator data associated with a surgical procedure to acloud-based system communicatively coupled to a plurality of surgicalhubs, as described above. In various aspects, the present disclosureprovides a non-transitory computer-readable medium storingcomputer-readable instructions which, when executed, causes a machine totransmit generator data associated with a surgical procedure to acloud-based system communicatively coupled to a plurality of surgicalhubs, as described above.

In another aspect, the present disclosure provides a cloud-based systemcommunicatively coupled to a plurality of surgical hubs. Each surgicalhub is configured to transmit generator data associated with a surgicalprocedure to the cloud-based system. The cloud-based system comprises aprocessor and a memory coupled to the processor. The memory storesinstructions executable by the processor to receive a datagram generatedby a surgical hub, decrypt the encrypted generator data of the receiveddatagram, verify integrity of the generator data based on the MAC,authenticate the surgical hub as the source of the datagram, andvalidate a transmission path followed by the datagram between thesurgical hub and the cloud-based system. The datagram comprisesgenerator data captured from a generator associated with the surgicalhub, a MAC generated by the surgical hub based on the generator data, asource identifier, and a destination identifier. The generator data hasbeen encrypted by the surgical hub. The encrypted generator data hasbeen structured into a data packet comprising at least two of thefollowing fields: a field that indicates the source of the data, aunique time stamp, a field indicating an energy mode, a field indicatingpower output, and a field indicating a duration of applied power.

In various aspects, the present disclosure provides a control circuit totransmit generator data associated with a surgical procedure to thecloud-based system. In various aspects, the present disclosure providesa non-transitory computer-readable medium storing computer-readableinstructions which, when executed, causes a machine to transmitgenerator data associated with a surgical procedure to the cloud-basedsystem.

In another aspect, the present disclosure provides a method, comprisingcapturing data from a combination generator of a surgical hub during asurgical procedure, wherein the combination generator is configured tosupply two or more different modes of energy. Encrypting the capturedgenerator data, generating a MAC based on the captured generator data,generating a datagram comprising the encrypted generator data, the MAC,a source identifier, and a destination identifier, and communicating thedatagram from the surgical hub to a cloud-based system. The datagramallows for the cloud-based system to authenticate integrity of thecommunicated generator data, authenticate the surgical hub as a sourceof the datagram, and determine a communication path followed by thedatagram between the surgical hub and the cloud-based system.

By sending captured generator data from a plurality of differentsurgical hubs to a cloud-based system, the cloud-based system is able toquickly build large data sets of information associated with multiplesurgical procedures performed in multiple locations over time.Furthermore, due to the composition of the respective datagrams, for agiven datagram, the cloud-based system is able to determine whether thedatagram was originally sent by one of the surgical hubs (sourcevalidation), thereby providing an indication that the generator datareceived at the cloud-based system is legitimate data. For the givendatagram, the cloud-based system is also able to determine whether thegenerator data received at the cloud-based system is identical to thegenerator data sent by the given surgical hub (data integrity), therebyallowing for the authenticity of the received generator data to beverified. Additionally, for the given datagram, the cloud-based systemis also able to re-trace the communication path followed by thedatagram, thereby allowing for enhanced troubleshooting if a datagramreceived by the cloud-based system was originally sent from a deviceother than the surgical hubs and/or if the content of the datagram wasaltered while in transit to the cloud-based system. Notably, the presentdisclosure references generator data in particular. Here, the presentdisclosure should not be limited as being able to process only generatordata. For example, the surgical hub 206 and/or the cloud-based system205 may process data received from any component (e.g., imaging module238, generator module 240, smoke evacuator module 226,suction/irrigation module 228, communication module 230, processormodule 232, storage array 234, smart device/instrument 235, non-contactsensor module 242, robot hub 222, a non-robotic surgical hub 206,wireless smart device/instrument 235, visualization system 208) of thesurgical system 202 that is coupled to the surgical hub 206 and/or datafrom any devices (e.g., endoscope 239, energy device 241) coupledto/through such components (e.g., see FIGS. 9-10), in a similar manneras discussed herein.

Unfortunately, the outcome of a surgical procedure is not alwaysoptimal. For example, a failure event such as a surgical device failure,an unwanted tissue perforation, an unwanted post-operative bleeding, orthe like can occur. The occurrence of a failure event can be attributedto any of a variety of different people and devices, including one ormore surgeons, one or more devices associated with the surgery, acondition of the patient, and combinations thereof. When a given failureevent occurs, it is not always clear regarding who or what caused thefailure event or how the occurrence of the failure event can bemitigated in connection with a future surgery.

During a given surgical procedure, a large amount of data associatedwith the surgical procedure can be generated and captured. All of thecaptured data can be communicated to a surgical hub, and the captureddata can be time-stamped either before or after being received at thesurgical hub. When a failure event associated with the surgicalprocedure is detected and/or identified, it can be determined which ofthe captured data is associated with the failure event and/or which ofthe captured data is not associated with the failure event. In makingthis determination, the failure event can be defined to include a periodof time prior to the detection/identification of the failure event. Oncethe determination is made regarding the captured data associated withthe failure event, the surgical hub can separate the captured dataassociated with the failure event from all other captured data, and thecaptured data can be separated based on tagging, flagging, or the like.The captured data associated with the failure event can then bechronologized based on the time-stamping and the defined time periodapplicable to the failure event. The chronologized captured data canthen be communicated to a cloud-based system on a prioritized basis foranalysis, where the prioritized basis is relative to the captured datawhich is not associated with the failure event. Whether or not theanalysis identifies a device associated with the surgical procedure asthe causation of the failure event, the surgical hub can tag the devicefor removal of the device from future use, further analysis of thedevice, and/or to return the device to the manufacturer.

When a given surgical procedure is performed, a large amount of dataassociated with the surgical procedure can be generated and captured.All of the captured data can be communicated to a surgical hub, wherethe information can be stripped of all “personal” associations. Thecaptured data can be time-stamped before being received at the surgicalhub, after being received at the surgical hub, before being stripped ofthe “personal” associations, or after being stripped of the “personal”associations. The surgical hub can communicate the stripped data to thecloud-based system for subsequent analysis. Over time, the cloud-basedsystem will receive large data sets of information associated with thesurgeries. Accordingly, in one aspect, the present disclosure provides asurgical hub for prioritizing surgical data associated with a surgicalprocedure to a cloud-based system communicatively coupled to a pluralityof surgical hubs. The surgical hub comprises a processor and a memorycoupled to the processor. The memory stores instructions executable bythe processor to capture surgical data, wherein the surgical datacomprises data associated with a surgical device, time-stamp thecaptured surgical data, identify a failure event, identify a time periodassociated with the failure event, isolate failure event surgical datafrom surgical data not associated with the failure event based on theidentified time period, chronologize the failure event surgical data bytime-stamp, encrypt the chronologized failure event surgical data,generate a datagram comprising the encrypted failure event surgicaldata, and transmit the datagram to a cloud-based system. The datagram isstructured to include a field which includes a flag that prioritizes theencrypted failure event surgical data over other encrypted data of thedatagram. The datagram allows for the cloud-based system to decrypt theencrypted failure event surgical data, focus analysis on the failureevent surgical data rather than surgical data not associated with thefailure event, and flag the surgical device associated with the failureevent for at least one of the following: removal from an operating room,return to a manufacturer, or future inoperability in the cloud-basedsystem.

In various aspects, the present disclosure provides a control circuit toprioritize surgical data associated with a surgical procedure to acloud-based system communicatively coupled to a plurality of surgicalhubs. In various aspects, the present disclosure provides anon-transitory computer-readable medium storing computer-readableinstructions which, when executed, causes a machine to prioritizesurgical data associated with a surgical procedure to a cloud-basedsystem communicatively coupled to a plurality of surgical hubs.

In another aspect, the present disclosure provides a method, comprisingcapturing data during a surgical procedure, communicating the captureddata to a surgical hub, time-stamping the captured data, identifying afailure event associated with the surgical procedure, determining whichof the captured data is associated with the failure event, separatingthe captured data associated with the failure event from all othercaptured data, chronologizing the captured data associated with thefailure event, and communicating the chronologized captured data to acloud-based system on a prioritized basis.

By capturing the large amount of data associated with the surgicalprocedure, and with having the captured data time-stamped, the portionof the captured data which is relevant to the detected/identifiedfailure event can be more easily isolated from all of the other captureddata, thereby allowing for a more focused subsequent analysis on justthe relevant captured data. The data associated with the failure eventcan then be chronologized (this requires less processing power thanchronologizing all of the captured data), thereby allowing for theevents leading up to the detection/identification of the failure eventto be more easily considered during the subsequent analysis of thefailure event. The chronologized data can then be communicated to thecloud-based system (this requires less communication resources thancommunicating all of the captured data at the same time) on aprioritized basis, thereby allowing for the focused subsequent analysisof the fault event to be performed by the cloud-based system in a moretime-sensitive manner.

To help ensure that the best practice recommendations are developedbased on accurate data, it would be desirable to ensure that thegenerator data received at the cloud-based system is the same as thegenerator data communicated to the cloud-based system. Also, to help tobe able to determine the cause of a failure event as quickly aspossible, it would be desirable to ensure that surgical data associatedwith the failure event is communicated to the cloud-based system in aprioritized manner (relative to surgical data not associated with thefailure event) so that analysis of the surgical data can be performed inan expedited manner.

Aspects of a system and method for communicating data associated with asurgical procedure are described herein. As shown in FIG. 9, variousaspects of the computer implemented interactive surgical system 200includes a device/instrument 235, a generator module 240, a modularcontrol tower 236, and a cloud-based system 205. As shown in FIG. 10,the device/instrument 235, the generator module 240, and the modularcontrol tower 236 are components/portions of a surgical hub 206.

In various aspects, the generator module 240 of the surgical hub 206 cansupply radio-frequency energy such as monopolar radio-frequency energy,bipolar radio-frequency energy, and advanced bipolar energy and/orultrasonic energy to a device/instrument 235 for use in a surgicalprocedure. Thus, the generator module 240 may be referred to as acombination generator. An example of such a combination generator isshown in FIG. 22, where the combination generator 3700 is shown asincluding a monopolar module 3702, a bipolar module 3704, an advancedbipolar module 3706, and an ultrasound module 3708. When utilized duringa surgical procedure, the respective energy modules (e.g., 3702, 3704,3706, and/or 3708) of the combination generator 3700 can providegenerator data such as type of energy supplied to the device instrument(e.g., radio-frequency energy, ultrasound energy, radio-frequency energyand ultrasound energy), type of radio-frequency energy (e.g., monopolar,bipolar, advanced bipolar), frequency, power output, duration, etc., tothe data communication module 3710 of the combination generator 3700.

FIG. 23 illustrates various aspects of a method of capturing data from acombination generator 3700 and communicating the captured generator datato a cloud-based system 205. Notably, as discussed herein, the presentdisclosure should not be limited to processing generator data. As such,the method of FIG. 23 similarly extends to other types of data receivedfrom other components coupled to the surgical hub 206 (e.g., imagingmodule data, smoke evacuator data, suction/irrigation data,device/instrument data). The method comprises (1) capturing 3712 datafrom a combination generator 3700 of a surgical hub 206 during asurgical procedure, wherein the combination generator 3700 is configuredto supply two or more different modes of energy; (2) encrypting 3714 thecaptured generator data; (3) generating 3716 a MAC based on the capturedgenerator data; (4) generating 3718 a datagram comprising the encryptedgenerator data, the MAC, a source identifier, and a destinationidentifier; and (5) communicating 3720 the datagram from the surgicalhub 206 to a cloud-based system 205, wherein the datagram allows for thecloud-based system 205 to (i) authenticate integrity of the communicatedgenerator data, (ii) authenticate the surgical hub as a source of thedatagram, and (iii) determine a communication path followed by thedatagram between the surgical hub 206 and the cloud-based system 205.

More specifically, once the generator data is received at the datacommunication module 3710 of the combination generator 3700, thegenerator data can be communicated to the modular communication hub 203of the surgical hub 206 for subsequent communication to the cloud-basedsystem 205. The data communication module 3710 can communicate thegenerator data to the modular communication hub 203 serially over asingle communication line or in parallel over a plurality ofcommunication lines, and such communication can be performed in realtime or near real time. Alternatively, such communication can beperformed in batches.

According to various aspects, prior to communicating the generator datato the modular communication hub 203, a component of the combinationgenerator 3700 (e.g., the data communication module 3710) can organizethe generator data into data packets. An example of such a data packetis shown in FIG. 24, where the data packet 3722 includes a preamble 3724or self-describing data header which defines what the data is (e.g.,combination generator data—CGD) and fields which indicate where thegenerator data came from [e.g., combination generator ID number3726—(e.g., 017), a unique time stamp 3728 (e.g., 08:27:16), the energymode utilized 3730 (e.g., RF, U, RF+U), the type of radio-frequencyenergy or radio frequency mode 3732 (e.g., MP, BP, ABP), the frequency3734 (e.g., 500 Khz), the power output 3736 (e.g., 30 watts), theduration of applied power 3738 (e.g., 45 milliseconds), and anauthentication/identification certificate of the data point 3740 (e.g.,01101011001011)]. The example data packet 3722 may be considered aself-describing data packet, and the combination generator 3700 andother intelligent devices (e.g., the surgical hub 206) can use theself-describing data packets to minimize data size and data-handlingresources. Again, as discussed herein, the present disclosure should notbe limited to processing generator data received from a combinationgenerator 3700. As such, the data packet 3722 of FIG. 24 similarlyextends to other types of data received from other components coupled tothe surgical hub 206. In one aspect, the data packet 3722 may comprisedata associated with endoscope 239 (e.g., image data) received from acomponent of the imaging module 238. In another aspect, the data packet3722 may comprises data associated with an evacuation system (e.g.,pressures, particle counts, flow rates, motor speeds) received from acomponent of the smoke evacuator module 226. In yet another aspect, thedata packet 3722 may comprise data associated with a device/instrument(e.g., temperature sensor data, firing data, sealing data) received froma component of the device/instrument 235. In various other aspects, thedata packet 3722 may similarly comprise data received from othercomponents coupled to the surgical hub 206 (e.g., suction/irrigationmodule 228, non-contact sensor module 242)

Additionally, the data communication module 3710 can compress thegenerator data and/or encrypt the generator data prior to communicatingthe generator data to the modular communication hub 203. The specificmethod of compressing and/or encrypting can be the same as or differentfrom the compressing and/or encrypting which may be performed by thesurgical hub 206 as described in more detail below.

The modular communication hub 203 can receive the generator datacommunicated from the combination generator 3700 (e.g., via the datacommunication module 3710), and the generator data can be subsequentlycommunicated to the cloud-based system 205 (e.g., through the Internet).According to various aspects, the modular communication hub 203 canreceive the generator data through a hub/switch 207/209 of the modularcommunication hub 203 (See FIG. 10), and the generator data can becommunicated to the cloud-based system 205 by a router 211 of themodular communication hub 203 (See FIG. 10). The generator data may becommunicated in real time, near real time, or in batches to thecloud-based system 205 or may be stored at the surgical hub 206 prior tobeing communicated to the cloud-based system 205. The generator data canbe stored, for example, at the storage array 234 or at the memory 249 ofthe computer system 210 of the surgical hub 206.

In various aspects, for instances where the generator data received atthe modular communication hub 203 is not encrypted, prior to thereceived generator data being communicated to the cloud-based system205, the generator data is encrypted to help ensure the confidentialityof the generator data, either while it is being stored at the surgicalhub 206 or while it is being transmitted to the cloud 204 using theInternet or other computer networks. According to various aspects, acomponent of the surgical hub 206 utilizes an encryption algorithm toconvert the generator data from a readable version to an encodedversion, thereby forming the encrypted generator data. The component ofthe surgical hub 206 which utilizes/executes the encryption algorithmcan be, for example, the processor module 232, the processor 244 of thecomputer system 210, and/or combinations thereof. The utilized/executedencryption algorithm can be a symmetric encryption algorithm and/or anasymmetric encryption algorithm.

Using a symmetric encryption algorithm, the surgical hub 206 wouldencrypt the generator data using a shared secret (e.g., private key,passphrase, password). In such an aspect, a recipient of the encryptedgenerator data (e.g., cloud-based system 205) would then decrypt theencrypted generator data using the same shared secret. In such anaspect, the surgical hub 206 and the recipient would need access toand/or knowledge of the same shared secret. In one aspect, a sharedsecret can be generated/chosen by the surgical hub 206 and securelydelivered (e.g., physically) to the recipient before encryptedcommunications to the recipient.

Alternatively, using an asymmetric encryption algorithm, the surgicalhub 206 would encrypt the generator data using a public key associatedwith a recipient (e.g., cloud-based system 205). This public key couldbe received by the surgical hub 206 from a certificate authority thatissues a digital certificate certifying the public key as owned by therecipient. The certificate authority can be any entity trusted by thesurgical hub 206 and the recipient. In such an aspect, the recipient ofthe encrypted generator data would then decrypt the encrypted generatordata using a private key (i.e., known only by the recipient) paired tothe public key used by the surgical hub 206 to encrypt the generatordata. Notably, in such an aspect, the encrypted generator data can onlybe decrypted using the recipient's private key.

According to aspects of the present disclosure, components (e.g.,surgical device/instrument 235, energy device 241, endoscope 239) of thesurgical system 202 are associated with unique identifiers, which can bein the form of serial numbers. As such, according to various aspects ofthe present disclosure, when a component is coupled to a surgical hub206, the component may establish a shared secret with the surgical hub206 using the unique identifier of the coupled component as the sharedsecret. Further, in such an aspect, the component may derive a checksumvalue by applying a checksum function/algorithm to the unique identifierand/or other data being communicated to the surgical hub 206. Here, thechecksum function/algorithm is configured to output a significantlydifferent checksum value if there is a modification to the underlyingdata.

In one aspect, the component may initially encrypt the unique identifierof a coupled component using a public key associated with the surgicalhub (e.g., received by the component from the surgical hub 206upon/after connection) and communicate the encrypted unique identifierto the surgical hub 206. In other aspects, the component may encrypt theunique identifier and the derived checksum value of a coupled componentusing a public key associated with the surgical hub 206 and communicatethe encrypted unique identifier and linked/associated checksum value tothe surgical hub 206.

In yet other aspects, the component may encrypt the unique identifierand a checksum function/algorithm using a public key associated with thesurgical hub 206 and communicate the encrypted unique identifier and thechecksum function/algorithm to the surgical hub 206. In such aspects,the surgical hub 206 would then decrypt the encrypted unique identifieror the encrypted unique identifier and the linked/associated checksumvalue or the encrypted unique identifier and the checksumfunction/algorithm using a private key (i.e., known only by the surgicalhub 206) paired to the public key used by the component to encrypt theunique identifier.

Since the encrypted unique identifier can only be decrypted using thesurgical hub's 206 private key and the private key is only known by thesurgical hub, this is a secure way to communicate a shared secret (e.g.,the unique identifier of the coupled component) to the surgical hub 206.Further, in aspects where a checksum value is linked to/associated withthe unique identifier, the surgical hub 206 may apply the same checksumfunction/algorithm to the decrypted unique identifier to generate avalidating checksum value. If the validating checksum value matches thedecrypted checksum value, the integrity of the decrypted uniqueidentifier is further verified. Further, in such aspects, with a sharedsecret established, the component can encrypt future communications tothe surgical hub 206, and the surgical hub 206 can decrypt the futurecommunications from the component using the shared secret (e.g., theunique identifier of the coupled component). Here, according to variousaspects, a checksum value may be derived for and communicated with eachcommunication between the component and the surgical hub 206 (e.g., thechecksum value based on the communicated data or at least a designatedportion thereof). Here, a checksum function/algorithm (e.g., known bythe surgical hub 206 and/or component or communicated when establishingthe shared secret between the surgical hub 206 and the component asdescribed above) may be used to generate validating checksum values forcomparison with communicated checksum values to further verify theintegrity of communicated data in each communication.

Notably, asymmetric encryption algorithms may be complex and may requiresignificant computational resources to execute each communication. Assuch, establishing the unique identifier of the coupled component as theshared secret is not only quicker (e.g., no need to generate a sharedsecret using a pseudorandom key generator) but also increasescomputational efficiency (e.g., enables the execution of faster, lesscomplex symmetric encryption algorithms) for all subsequentcommunications. In various aspects, this established shared secret maybe utilized by the component and surgical hub 206 until the component isdecoupled from the surgical hub (e.g., surgical procedure ended).

According to other aspects of the present disclosure, components (e.g.,surgical device/instrument 235, energy device 241, endoscope 239) of thesurgical system 202 may comprise sub-components (e.g., handle, shaft,end effector, cartridge) each associated with its own unique identifier.As such, according to various aspects of the present disclosure, when acomponent is coupled to the surgical hub 206, the component mayestablish a shared secret with the surgical hub 206 using a uniquecompilation/string (e.g., ordered or random) of the unique identifiersassociated with the sub-components that combine to form the coupledcomponent. In one aspect, the component may initially encrypt the uniquecompilation/string of the coupled component using a public keyassociated with the surgical hub 206 and communicate the encryptedunique compilation/string to the surgical hub 206. In such an aspect,the surgical hub 206 would then decrypt the encrypted uniquecompilation/string using a private key (i.e., known only by the surgicalhub 206) paired to the public key used by the component to encrypt theunique compilation/string. Since the encrypted unique compilation/stringcan only be decrypted using the surgical hub's 206 private key and theprivate key is only known by the surgical hub 206, this is a secure wayto communicate a shared secret (e.g., the unique compilation/string ofthe coupled component) to the surgical hub 206. Further, in such anaspect, with a shared secret established, the component can encryptfuture communications to the surgical hub 206, and the surgical hub 206can decrypt the future communications from the component using theshared secret (e.g., the unique compilation/string of the coupledcomponent).

Again, asymmetric encryption algorithms may be complex and may requiresignificant computational resources to execute each communication. Assuch, establishing the unique compilation/string of the coupledcomponent (i.e., readily combinable by the component) as the sharedsecret is not only quicker (e.g., no need to generate a shared secretusing a pseudorandom key generator) but also increases computationalefficiency (e.g., enables the execution of faster, less complexsymmetric encryption algorithms) for all subsequent communications. Invarious aspects, this established shared secret may be utilized by thecomponent and surgical hub 206 until the component is decoupled from thesurgical hub 206 (e.g., surgical procedure ended). Furthermore, in suchan aspect, since various sub-components may be reusable (e.g., handle,shaft, end effector) while other sub-components may not be reusable(e.g., end effector, cartridge) each new combination of sub-componentsthat combine to form the coupled component provide a uniquecompilation/string usable as a shared secret for componentcommunications to the surgical hub 206.

According to further aspects of the present disclosure, components(e.g., surgical device/instrument 235, energy device 241, endoscope 239)of the surgical system 202 are associated with unique identifiers. Assuch, according to various aspects of the present disclosure, when acomponent is coupled to the surgical hub 206, the surgical hub 206 mayestablish a shared secret with a recipient (e.g., cloud-based system205) using the unique identifier of the coupled component. In oneaspect, the surgical hub 206 may initially encrypt the unique identifierof a coupled component using a public key associated with the recipientand communicate the encrypted unique identifier to the recipient. Insuch an aspect, the recipient would then decrypt the encrypted uniqueidentifier using a private key (i.e., known only by the recipient)paired to the public key used by the surgical hub 206 to encrypt theunique identifier. Since the encrypted unique identifier can only bedecrypted using the recipient's private key and the private key is onlyknown by the recipient, this is a secure way to communicate a sharedsecret (e.g., the unique identifier of the coupled component) to therecipient (e.g., cloud-based system). Further in such an aspect, with ashared secret established, the surgical hub 206 can encrypt futurecommunications to the recipient (e.g., cloud-based system 205), and therecipient can decrypt the future communications from the surgical hub206 using the shared secret (e.g., the unique identifier of the coupledcomponent).

Notably, asymmetric encryption algorithms may be complex and may requiresignificant computational resources to execute each communication. Assuch, establishing the unique identifier of the coupled component (i.e.,already available to the surgical hub 206) as the shared secret is notonly quicker (e.g., no need to generate a shared secret using apseudorandom key generator) but also increases computational efficiencyby, for example, enabling the execution of faster, less complexsymmetric encryption algorithms for all subsequent communications. Invarious aspects, this established shared secret may be utilized by thesurgical hub 206 until the component is decoupled from the surgical hub(e.g., surgical procedure ended).

According to yet further aspects of the present disclosure, components(e.g., surgical device/instrument 235, energy device 241, endoscope 239)of the surgical system 202 may comprise sub-components (e.g., handle,shaft, end effector, cartridge) each associated with its own uniqueidentifier. As such, according to various aspects of the presentdisclosure, when a component is coupled to the surgical hub 206, thesurgical hub 206 may establish a shared secret with a recipient (e.g.,cloud-based system 205) using a unique compilation/string (e.g., orderedor random) of the unique identifiers associated with the sub-componentsthat combine to form the coupled component.

In one aspect, the surgical hub 206 may initially encrypt the uniquecompilation/string of the coupled component using a public keyassociated with the recipient and communicate the encrypted uniquecompilation/string to the recipient. In such an aspect, the recipientwould then decrypt the encrypted unique compilation/string using aprivate key (i.e., known only by the recipient) paired to the public keyused by the surgical hub 206 to encrypt the unique compilation/string.Since the encrypted unique compilation/string can only be decryptedusing the recipient's private key and the private key is only known bythe recipient, this is a secure way to communicate a shared secret(e.g., the unique compilation/string of the coupled component) to therecipient. With a shared secret established, the surgical hub 206 canencrypt future communications to the recipient (e.g., cloud-based system205), and the recipient can decrypt the future communications from thesurgical hub 206 using the shared secret (e.g., the uniquecompilation/string of the coupled component). Again, asymmetricencryption algorithms may be complex and may require significantcomputational resources to execute each communication. As such,establishing the unique compilation/string of the coupled component(i.e., readily combinable by the surgical hub 206) as the shared secretis not only quicker (e.g., no need to generate a shared secret using apseudorandom key generator) but also increases computational efficiency(e.g., enables the execution of faster, less complex symmetricencryption algorithms) for all subsequent communications.

In various aspects, this established shared secret may be utilized bythe surgical hub 206 until the component is decoupled from the surgicalhub (e.g., surgical procedure ended). Furthermore, in such an aspect,since various sub-components may be reusable (e.g., handle, shaft, endeffector) while other sub-components may not be reusable (e.g., endeffector, cartridge) each new combination of sub-components that combineto form the coupled component provide a unique compilation/string usableas a shared secret for surgical hub 206 communications to the recipient.

In some aspects, an encrypt-then-MAC (EtM) approach may be utilized toproduce the encrypted generator data. An example of this approach isshown in FIG. 25, where the non-encrypted generator data (i.e., theplaintext 3742, e.g., data packet 3722) is first encrypted 3743 (e.g.,via key 3746) to produce a ciphertext 3744 (i.e., the encryptedgenerator data), then a MAC 3745 is produced based on the resultingciphertext 3744, the key 3746, and a MAC algorithm (e.g., a hashfunction 3747). More specifically, the ciphertext 3744 is processedthrough the MAC algorithm using the key 3746. In one aspect similar tosymmetric encryption discussed herein, the key 3746 is a secret keyaccessible/known by the surgical hub 206 and the recipient (e.g.,cloud-based system 205). In such an aspect, the secret key is a sharedsecret associated with/chosen by the surgical hub 206, a shared secretassociated with/chosen by the recipient, or a key selected via apseudorandom key generator. For this approach, as shown generally at3748, the encrypted generator data (i.e., the ciphertext 3744) and theMAC 3745 would be communicated together to the cloud-based system 205.

In other aspects, an encrypt-and-MAC (E&M) approach may be utilized toproduce the encrypted generator data. An example of this approach isshown in FIG. 26, where the MAC 3755 is produced based on thenon-encrypted generator data (i.e., the plaintext 3752, e.g., datapacket 3722), a key 3756, and a MAC algorithm (e.g., a hash function3757). More specifically, the plaintext 3752 is processed through theMAC algorithm using the key 3756. In one aspect similar to symmetricencryption discussed herein, the key 3756 is a secret keyaccessible/known by the surgical hub 206 and the recipient (e.g.,cloud-based system 205). In such an aspect, the secret key is a sharedsecret associated with/chosen by the surgical hub 206, a shared secretassociated with/chosen by the recipient, or a key selected via apseudorandom key generator. Further, in such an aspect, thenon-encrypted generator data (i.e., the plaintext 3752, e.g., datapacket 3722) is encrypted 3753 (e.g., via key 3756) to produce aciphertext 3754. For this approach, as shown generally at 3758, the MAC3755 (i.e., produced based on the non-encrypted generator data) and theencrypted generator data (i.e., the ciphertext 3754) would becommunicated together to the cloud-based system 205.

In yet other aspects, a MAC-then-encrypt (MtE) approach may be utilizedto produce the encrypted generator data. An example of this approach isshown in FIG. 27, where the MAC 3765 is produced based on thenon-encrypted generator data (i.e., the plaintext 3762), a key 3766, anda MAC algorithm (e.g., a hash function 3767). More specifically, theplaintext 3762 is processed through the MAC algorithm using the key3766. In one aspect similar to symmetric encryption discussed herein,the key 3766 is a secret key accessible/known by the surgical hub 206and the recipient (e.g., cloud-based system 205). In such an aspect, thesecret key is a shared secret associated with/chosen by the surgical hub206, a shared secret associated with/chosen by the recipient, or a keyselected via a pseudorandom key generator. Next, the non-encryptedgenerator data (i.e., the plaintext 3762) and the MAC 3765 are togetherencrypted 3763 (e.g., via key 3766) to produce a ciphertext 3764 basedon both. For this approach, as shown generally at 3768, the ciphertext3764 (i.e., which includes the encrypted generator data and theencrypted MAC 3765) would be communicated to the cloud-based system 205.

In alternative aspects, the key used to encrypt the non-encryptedgenerator data (e.g., FIG. 25 and FIG. 26) or the non-encryptedgenerator data and the MAC (e.g., FIG. 27) may be different from the key(e.g., keys 3746, 3756, 3766) used to produce the MAC. For example, thekey used to encrypt the non-encrypted generator data (e.g., FIG. 25 andFIG. 26) or the non-encrypted generator data and the MAC (e.g., FIG. 27)may be a different shared secret or a public key associated with therecipient.

In lieu of utilizing the MAC to provide for a subsequent assurance ofdata integrity to the cloud-based system 205, according to otheraspects, the surgical hub 206 can utilize a digital signature to allowthe cloud-based system 205 to subsequently authenticate integrity of thecommunicated generator data. For example, the processor module 232and/or the processor 244 of the computer system 210 can utilize one ormore algorithms to generate a digital signature associated with thegenerator data, and the cloud-based system 205 can utilize an algorithmto determine the authenticity of the received generator data. Thealgorithms utilized by the processor module 232 and/or the processor 244of the computer system 210 can include: (1) a key generation algorithmthat selects a private key uniformly at random from a set of possibleprivate keys, where the key generation algorithm outputs the private keyand a corresponding public key; and (2) a signing algorithm that, giventhe generator data and a private key, produces a digital signatureassociated with the generator data. The cloud-based system 205 canutilize a signature verifying algorithm that, given the receivedgenerator data, public key, and digital signature, can accept thereceived generator data as authentic if the digital signature isdetermined to be authentic or consider the generator data to becompromised or altered if the digital signature is not determined to beauthentic.

According to other aspects of the present disclosure, the surgical hub206 can utilize a commercial authentication program (e.g., Secure HashAlgorithm, SHA-2 comprising SHA-256) to provide for a subsequentassurance of data integrity of the communicated generator data to thecloud-based system 205.

After the generator data has been encrypted (e.g., via EtM, E&M, MtE), acomponent of the surgical hub 206 can communicate the encryptedgenerator data to the cloud-based system 205. The component of thesurgical hub 206 which communicates the encrypted generator data to thecloud-based system 205 can be, for example, the processor module 232, ahub/switch 207/209 of the modular communication hub 203, the router 211of the modular communication hub 203, the communication module 247 ofthe computer system 210, etc.

According to various aspects, the communication of the encryptedgenerator data through the Internet can follow an IP which: (1) definesdatagrams that encapsulate the encrypted generator data to be deliveredand/or (2) defines addressing methods that are used to label thedatagram with source and destination information. A high-levelrepresentation of an example datagram 3770 is shown in FIG. 28, wherethe datagram 3770 includes a header 3772 and a payload 3774, and inother aspects also may include a trailer (not shown). A more detailedrepresentation of an example datagram 3780 is shown in FIG. 29, wherethe header 3782 can include fields for information such as, for example,the IP address of the source 3786 which is sending the datagram (e.g.,the router 211 of the modular communication hub 203), the IP address ofthe destination 3788 which is to receive the datagram (e.g., the cloud204 and/or the remote server 213 associated with the cloud-based system205), a type of service designation (not shown), a header length 3790, apayload length 3792, and a checksum value 3794. In such an aspect, thesurgical hub 206 may further apply a checksum function/algorithm to thenon-encrypted generator data (i.e., the plaintext 3742, e.g., datapacket 3722) or at least a portion of the non-encrypted generator data(e.g., combination generator ID 3726) to derive the checksum value 3794.Here, the checksum function/algorithm is configured to output asignificantly different checksum value if there is any modification(e.g., even a slight change) to the underlying data (e.g., generatordata). After decryption of the encrypted generator data by its recipient(e.g., cloud-based system 205), the recipient may apply the samechecksum function/algorithm to the decrypted generator data to generatea validating checksum value. If the validating checksum value matchesthe checksum value 3794 (i.e., stored in the header 3782 of the receiveddatagram 3780), the integrity of the received generator data is furtherverified. The payload 3784 may include the encrypted generator data 3796and can also include padding 3798 if the encrypted generator data 3796is less than a specified payload length. Notably, the communicatedencrypted generator data 3796 may comprise a MAC as discussed in FIGS.25, 26, and 27 above (e.g., references 3748, 3758, and 3768,respectively). In some aspects, the header 3782 can further include aspecific path the datagram is to follow when the datagram iscommunicated from the surgical hub 206 to the cloud-based system 205(e.g., from IP address of the source, to IP address of at least oneintermediate network component (e.g., specified routers, specifiedservers), to IP address of the destination).

According to various aspects, prior to the generator data beingencrypted, the generator data can be time-stamped (if not alreadytime-stamped by the combination generator 3700) and/or the generatordata can be compressed (if not already compressed by the combinationgenerator 3700). Time-stamping allows for the cloud-based system 205 tocorrelate the generator data with other data (e.g., stripped patientdata) which may be communicated to the cloud-based system 205. Thecompression allows for a smaller representation of the generator data tobe subsequently encrypted and communicated to the cloud-based system205. For the compression, a component of the surgical hub 206 canutilize a compression algorithm to convert a representation of thegenerator data to a smaller representation of the generator data,thereby allowing for a more efficient and economical encryption of thegenerator data (e.g., less data to encrypt utilizes less processingresources) and a more efficient and economical communication of theencrypted generator data (e.g., smaller representations of the generatordata within the payload of the datagrams (e.g., FIGS. 28 and 29) allowfor more generator data to be included in a given datagram, for moregenerator data to be communicated within a given time period, and/or forgenerator data to be communicated with fewer communication resources).The component of the surgical hub 206 which utilizes/executes thecompression algorithm can be, for example, the processor module 232, theprocessor 244 of the computer system, and/or combinations thereof. Theutilized/executed compression algorithm can be a lossless compressionalgorithm or a lossy compression algorithm.

Once the generator data and the MAC for a given datagram has beenreceived at the cloud-based system 205 (e.g., FIG. 25, reference 3748;FIG. 26, reference 3758; and FIG. 27, reference 3768), the cloud-basedsystem 205 can decrypt the encrypted generator data from the payload ofthe communicated datagram to realize the communicated generator data.

In one aspect, referring back to FIG. 25, the recipient (e.g.,cloud-based system 205) may, similar to the surgical hub 206, processthe ciphertext 3744 through the same MAC algorithm using the sameknown/accessible secret key to produce an authenticating MAC. If thereceived MAC 3745 matches this authenticating MAC, the recipient (e.g.,cloud-based system 205) may safely assume that the ciphertext 3744 hasnot been altered and is from the surgical hub 206. The recipient (e.g.,cloud-based system 205) may then decrypt the ciphertext 3744 (e.g., viakey 3746) to realize the plaintext 3742 (e.g., data packet comprisinggenerator data).

In another aspect, referring back to FIG. 26, the recipient (e.g.,cloud-based system 205) may decrypt the ciphertext 3754 (e.g., via key3756) to realize the plaintext 3752 (e.g., data packet comprisinggenerator data). Next, similar to the surgical hub 206, the recipient(e.g., cloud-based system 205) may process the plaintext 3752 throughthe same MAC algorithm using the same known/accessible secret key toproduce an authenticating MAC. If the received MAC 3755 matches thisauthenticating MAC, the recipient (e.g., cloud-based system 205) maysafely assume that the plaintext 3752 has not been altered and is fromthe surgical hub 206.

In yet another aspect, referring back to FIG. 27, the recipient (e.g.,cloud-based system 205) may decrypt the ciphertext 3764 (e.g., via key3766) to realize the plaintext 3762 (e.g., data packet comprisinggenerator data) and the MAC 3765. Next, similar to the surgical hub 206,the recipient (e.g., cloud-based system 205) may process the plaintext3762 through the same MAC algorithm using the same known/accessiblesecret key to produce an authenticating MAC. If the received MAC 3765matches this authenticating MAC, the recipient (e.g., cloud-based system205) may safely assume that the plaintext 3762 has not been altered andis from the surgical hub 206.

In alternative aspects, the key used to encrypt the non-encryptedgenerator data (e.g., FIG. 25 and FIG. 26) or the non-encryptedgenerator data and the MAC (e.g., FIG. 27) may be different from the key(e.g., keys 3746, 3756, 3766) used to produce the MAC. For example, thekey used to encrypt the non-encrypted generator data (e.g., FIG. 25 andFIG. 26) or the non-encrypted generator data and the MAC (e.g., FIG. 27)may be a different shared secret or a public key associated with therecipient. In such aspects, referring to FIG. 25, the recipient (e.g.,cloud-based system 205) may, after verifying the authenticating MAC viakey 3746 (described above), then decrypt the ciphertext 3744 (e.g., viathe different shared secret or private key associated with therecipient) to realize the plaintext 3742 (e.g., data packet comprisinggenerator data). In such aspects, referring to FIG. 26, the recipientmay decrypt the ciphertext 3754 (e.g., via the different shared secretor private key associated with the recipient) to realize the plaintext3752 (e.g., data packet comprising generator data), then verify theauthenticating MAC via key 3756 (described above). In such aspects,referring to FIG. 27, the recipient may decrypt the ciphertext 3764(e.g., via the different shared secret or private key associated withthe recipient) to realize the plaintext 3762 (e.g., data packetcomprising generator data) and the MAC 3765, then verify theauthenticating MAC via key 3766 (described above).

In sum, referring to FIGS. 25-27, if an authenticating MAC, asdetermined/calculated by the cloud-based system 205, is the same as theMAC which was received with the datagram, the cloud-based system 205 canhave confidence that the received generator data is authentic (i.e., itis the same as the generator data which was communicated by the surgicalhub 206) and that the data integrity of the communicated generator datahas not been compromised or altered. As described above, the recipientmay further apply the plaintext 3742, 3752, 3762, or at least a portionthereof to the same checksum function/algorithm (i.e., used by thesurgical hub 206) to generate a validating checksum value to furtherverify the integrity of the generator data based on the checksum valuestored in the header of the communicated datagram.

Additionally, based on the decrypted datagram, the IP address of thesource (e.g., FIG. 29, reference 3786) which originally communicated thedatagram to the cloud-based system 205 can be determined from the headerof the communicated datagram. If the determined source is a recognizedsource, the cloud-based system 205 can have confidence that thegenerator data originated from a trusted source, thereby providingsource authentication and even more assurance of the data integrity ofthe generator data. Furthermore, since each router the datagram passedthrough in route to the cloud-based system 205 includes its IP addresswith its forwarded communication, the cloud-based system 205 is able totrace back the path followed by the datagram and identify each routerwhich handled the datagram. The ability to identify the respectiverouters can be helpful in instances where the content of the datagramreceived at the cloud-based system 205 is not the same as the content ofthe datagram as originally communicated by the surgical hub 206. Foraspects where the communication path was pre-specified and included inthe header of the communicated datagram, the ability to identify therespective routers can allow for path validation and provide additionalconfidence of the authenticity of the received generator data.

Furthermore, according to various aspects, after authenticating thereceived generator data, the cloud-based system 205 can communicate amessage (e.g., a handshake or similar message) to the surgical hub 206via the Internet or another communication network,confirming/guaranteeing that the datagram communicated from the surgicalhub 206 was received intact by the cloud-based system 205, therebyeffectively closing the loop for that particular datagram.

Aspects of the above-described communication method, and/or variationsthereof, can also be employed to communicate data other than generatordata to the cloud-based system 205 and/or to communicate generator dataand/or other data from the surgical hub 206 to systems and/or devicesother than the cloud-based system 205. For example, according to variousaspects, the generator data and/or other data can be communicated fromthe surgical hub 206 to a hand-held surgical device/instrument (e.g.,wireless device/instrument 235), to a robotic interface of a surgicaldevice/instrument (e.g., robot hub 222) and/or to other servers,including servers (e.g., similar to server 213) associated with othercloud-based systems (e.g., similar to cloud-based system 205) inaccordance with the above-described communication method. For example,in certain instances, an EEPROM chip of a given surgical instrument caninitially be provided with merely an electronic chip device ID. Uponconnection of the given surgical instrument to the combination generator3700, data can be downloaded from the cloud-based system 205 to thesurgical hub 206 and subsequently to the EEPROM of the surgicalinstrument in accordance with the above-described communication method.

In addition to communicating generator data to the cloud-based system205, the surgical hub 206 can also utilize the above-described method ofcommunication, and/or variations thereof, to communicate data other thangenerator data to the cloud-based system 205. For example, the surgicalhub 206 can also communicate other information associated with thesurgical procedure to the cloud-based system 205. Such other informationcan include, for example, the type of surgical procedure beingperformed, the name of the facility where the surgical procedure isbeing performed, the location of the facility where the surgicalprocedure is being performed, an identification of the operating roomwithin the facility where the surgical procedure is being performed, thename of the surgeon performing the surgical procedure, the age of thepatient, and data associated with the condition of the patient (e.g.,blood pressure, heart rate, current medications). According to variousaspects, such other information may be stripped of all information whichcould identify the specific surgery, the patient, or the surgeon, sothat the information is essentially anonymized for further processingand analysis by the cloud-based system 205. In other words, the strippeddata is not correlated to a specific surgery, patient, or surgeon. Thestripped information can be communicated to the cloud-based system 205either together with or distinct from the communicated generator data.

For instances where the stripped/other data is to be communicated apartfrom the generator data, the stripped/other data can be time-stamped,compressed, and/or encrypted in a manner identical to or different fromthat described above regarding the generator data, and the surgical hub206 may be programmed/configured to generate a datagram which includesthe encrypted stripped/other information in lieu of the encryptedgenerator data. The datagram can then be communicated from the surgicalhub 206 through the Internet to the cloud-based system 205 following anIP which: (1) defines datagrams that encapsulate the encryptedstripped/other data to be delivered, and (2) defines addressing methodsthat are used to label the datagram with source and destinationinformation.

For instances where the stripped/other information is to be communicatedwith the generator data, the stripped/other data can be time-stamped,compressed, and/or encrypted in a manner identical to or different fromthat described above regarding the generator data, and the surgical hub206 may be programmed/configured to generate a datagram which includesboth the encrypted generator data and the encrypted stripped/otherinformation. An example of such a datagram in shown in FIG. 30, wherethe payload 3804 of the datagram 3800 is divided into two or moredistinct payload data portions (e.g., one for the encrypted generatordata 3834, one for the encrypted stripped/other information 3836), witheach portion having an identifying bit (e.g., generator data (GD) 3806,other data (OD) 3812), the associated encrypted data 3808, 3814, and theassociated padding 3810, 3816, if needed, respectively. Further, asshown in FIG. 30, the header 3802 may be the same as (e.g., IP addresssource 3818, IP address destination 3820, header length 3822) ordifferent from the header 3782 described with reference to the datagram3780 shown in FIG. 29. For example, the header 3802 may be different inthat the header 3802 further includes a field designating the number ofpayload data portions 3824 (e.g., 2) included in the payload 3804 of thedatagram 3800. The header 3802 can also be different in that it caninclude fields designating the payload length 3826, 3830 and thechecksum value 3828, 2832 for each payload data portion 3834, 3836,respectively. Although only two payload data portions are shown in FIG.30, it will be appreciated that the payload 3804 of the datagram 3800may include any quantity/number of payload data portions (e.g., 1, 2, 3,4, 5), where each payload data portion includes data associated with adifferent aspect of the surgical procedure. The datagram 3800 can thenbe communicated from the surgical hub 206 through the Internet to thecloud-based system 205 following an IP which: (1) defines datagrams thatencapsulate the encrypted generator data and the encryptedstripped/other data to be delivered, and (2) defines addressing methodsthat are used to label the datagram with source and destinationinformation.

As set forth above, it is an unfortunate reality that the outcomes ofall surgical procedures are not always optimal and/or successful. Forinstances where a failure event is detected and/or identified, avariation of the above-described communication methods can be utilizedto isolate surgical data which is associated with the failure event(e.g., failure event surgical data) from surgical data which is notassociated with the failure event (e.g., non-failure event surgicaldata) and communicate the surgical data which is associated with thefailure event (e.g., failure event data) from the surgical hub 206 tothe cloud-based system 205 on a prioritized basis for analysis.According to one aspect of the present disclosure, failure eventsurgical data is communicated from the surgical hub 206 to thecloud-based system 205 on a prioritized basis relative to non-failureevent surgical data.

FIG. 31 illustrates various aspects of a system-implemented method ofidentifying surgical data associated with a failure event (e.g., failureevent surgical data) and communicating the identified surgical data to acloud-based system 205 on a prioritized basis. The method comprises (1)receiving 3838 surgical data at a surgical hub 206, wherein the surgicaldata is associated with a surgical procedure; (2) time-stamping 3840 thesurgical data; (3) identifying 3842 a failure event associated with thesurgical procedure; (4) determining 3844 which of the surgical data isassociated with the failure event (e.g., failure event surgical data);(5) separating 3846 the surgical data associated with the failure eventfrom all other surgical data (e.g., non-failure event surgical data)received at the surgical hub 206; (6) chronologizing 3848 the surgicaldata associated with the failure event; (7) encrypting 3850 the surgicaldata associated with the failure event; and (8) communicating 3852 theencrypted surgical data to a cloud-based system 205 on a prioritizedbasis.

More specifically, various surgical data can be captured during asurgical procedure and the captured surgical data, as well as othersurgical data associated with the surgical procedure, can becommunicated to the surgical hub 206. The surgical data can include, forexample, data associated with a surgical device/instrument (e.g., FIG.9, surgical device/instrument 235) utilized during the surgery, dataassociated with the patient, data associated with the facility where thesurgical procedure was performed, and data associated with the surgeon.Either prior to or subsequent to the surgical data being communicated toand received by the surgical hub 206, the surgical data can betime-stamped and/or stripped of all information which could identify thespecific surgery, the patient, or the surgeon, so that the informationis essentially anonymized for further processing and analysis by thecloud-based system 205.

Once a failure event has been detected and/or identified (e.g., whichcan be either during or after the surgical procedure), the surgical hub206 can determine which of the surgical data is associated with thefailure event (e.g., failure event surgical data) and which of thesurgical data is not associated with the surgical event (e.g.,non-failure event surgical data). According to one aspect of the presentdisclosure, a failure event can include, for example, a detection of oneor more misfired staples during a stapling portion of a surgicalprocedure. For example, in one aspect, referring to FIG. 9, an endoscope239 may take snapshots while a surgical device/instrument 235 comprisingan end effector including a staple cartridge performs a stapling portionof a surgical procedure. In such an aspect, an imaging module 238 maycompare the snapshots to stored images and/or images downloaded from thecloud-based system 205 that convey correctly fired staples to detect amisfired staple and/or evidence of a misfired staple (e.g., a leak). Inanother aspect, the imaging module 238 may analyze the snapshotsthemselves to detect a misfired staple and/or evidence of a misfiredstaple. In one alternative aspect, the surgical hub 206 may communicatethe snapshots to the cloud-based system 205, and a component of thecloud-based system 205 may perform the various imaging module functionsdescribed above to detect a misfired staple and/or evidence of amisfired staple and to report the detection to the surgical hub 206.According to another aspect of the present disclosure, a failure eventcan include a detection of a tissue temperature which is below theexpected temperature during a tissue-sealing portion of a surgicalprocedure and/or a visual indication of excessive bleeding or oozingfollowing a surgical procedure (e.g., FIG. 9, via endoscope 239). Forexample, in one aspect, referring to FIG. 9, the surgicaldevice/instrument 235 may comprise an end effector, including atemperature sensor and the surgical hub 206, and/or the cloud-basedsystem may compare at least one temperature detected by the temperaturesensor (e.g., during a tissue-sealing portion of a surgical procedure)to a stored temperature and/or a range of temperatures expected and/orassociated with that surgical procedure to detect an inadequate/lowsealing temperature. In another aspect, an endoscope 239 may takesnapshots during a surgical procedure. In such an aspect, an imagingmodule 238 may compare the snapshots to stored images and/or imagesdownloaded from the cloud-based system 205 that convey tissue correctlysealed at expected temperatures to detect evidence of animproper/insufficient sealing temperature (e.g., charring,oozing/bleeding). Further, in such an aspect, the imaging module 238 mayanalyze the snapshots themselves to detect evidence of animproper/insufficient sealing temperature (e.g., charring,oozing/bleeding). In one alternative aspect, the surgical hub 206 maycommunicate the snapshots to the cloud-based system 205, and a componentof the cloud-based system 205 may perform the various imaging modulefunctions described above to detect evidence of an improper/insufficientsealing temperature and to report the detection to the surgical hub 206.According to the various aspects described above, in response to thedetected and/or identified failure event, the surgical hub 206 maydownload a program from the cloud-based system 205 for execution by thesurgical device/instrument 235 that corrects the detected issue (i.e.,program that alters surgical device/instrument parameters to preventmisfired staples, program that alters surgical device/instrumentparameters to ensure correct sealing temperature).

In some aspects, a failure event is deemed to cover a certain timeperiod, and all surgical data associated with that certain time periodcan be deemed to be associated with the failure event.

After the surgical data associated with the failure event has beenidentified, the identified surgical data (e.g., failure event surgicaldata) can be separated or isolated from all of the other surgical dataassociated with the surgical procedure (e.g., non-failure event surgicaldata). The separation can be realized, for example, by tagging orflagging the identified surgical data, by storing the identifiedsurgical data apart from all of the other surgical data associated withthe surgical procedure, or by storing only the other surgical data whilecontinuing to process the identified surgical data for subsequentprioritized communication to the cloud-based system 205. According tovarious aspects, the tagging or flagging of the identified surgical datacan occur during the communication process when the datagram isgenerated as described in more detail below.

The time-stamping of all of the surgical data (e.g., either before orafter the surgical data is received at the surgical hub) can be utilizedby a component of the surgical hub 206 to chronologize the identifiedsurgical data associated with the failure event. The component of thesurgical hub 206 which utilizes the time-stamping to chronologize theidentified surgical data can be, for example, the processor module 232,the processor 244 of the computer system 210, and/or combinationsthereof. By chronologizing the identified surgical data, the cloud-basedsystem 205 and/or other interested parties can subsequently betterunderstand the conditions which were present leading up to theoccurrence of the failure event and possibly pinpoint the exact cause ofthe failure event, thereby providing the knowledge to potentiallymitigate a similar failure event from occurring during a similarsurgical procedure performed at a future date.

Once the identified surgical data has been chronologized, thechronologized surgical data may be encrypted in a manner similar to thatdescribed above with respect to the encryption of the generator data.Thus, the identified surgical data can be encrypted to help ensure theconfidentiality of the identified surgical data, either while it isbeing stored at the surgical hub 206 or while it is being transmitted tothe cloud-based system 205 using the Internet or other computernetworks. According to various aspects, a component of the surgical hub206 utilizes an encryption algorithm to convert the identified surgicaldata from a readable version to an encoded version, thereby forming theencrypted surgical data associated with the failure event (e.g., FIGS.25-27). The component of the surgical hub which utilizes the encryptionalgorithm can be, for example, the processor module 232, the processor244 of the computer system 210, and/or combinations thereof. Theutilized encryption algorithm can be a symmetric encryption algorithm oran asymmetric encryption algorithm.

After the identified surgical data has been encrypted, a component ofthe surgical hub can communicate the encrypted surgical data associatedwith the failure event (e.g., encrypted failure event surgical data) tothe cloud-based system 205. The component of the surgical hub whichcommunicates the encrypted surgical data to the cloud-based system 205can be, for example, the processor module 232, a hub/switch 207/209 ofthe modular communication hub 203, the router 211 of the modularcommunication hub 203, or the communication module 247 of the computersystem 210. According to various aspects, the communication of theencrypted surgical data (e.g., encrypted failure event surgical data)through the Internet can follow an IP which: (1) defines datagrams thatencapsulate the encrypted surgical data to be delivered, and (2) definesaddressing methods that are used to label the datagram with source anddestination information. The datagram can be similar to the datagramshown in FIG. 29 or the datagram shown in FIG. 30, but can be differentin that either the header or the payload of the datagram can include afield which includes a flag or a tag which identifies the encryptedsurgical data (e.g., encrypted failure event surgical data) as beingprioritized relative to other non-prioritized surgical data (e.g.,encrypted non-failure event surgical data). An example of such adatagram is shown in FIG. 32, where the payload 3864 of the datagram3860 includes a field which indicates (e.g., a prioritized designation3834) that the payload 3864 includes prioritized surgical data (e.g.,combination generator data 3868). According to various aspects, thepayload 3864 of the datagram 3860 can also includenon-flagged/non-tagged/non-prioritized surgical data 3836 (e.g., othersurgical data 3874) as shown in FIG. 32.

According to various aspects, prior to the identified surgical data(e.g., failure event surgical data) being encrypted, the identifiedsurgical data can be compressed (if not already compressed by thesource(s) of the relevant surgical data). The compression allows for asmaller representation of the surgical data associated with the failureevent to be subsequently encrypted and communicated to the cloud-basedsystem 205. For the compression, a component of the surgical hub 206 canutilize a compression algorithm to convert a representation of theidentified surgical data to a smaller representation of the identifiedsurgical data, thereby allowing for a more efficient and economicalencryption of the identified surgical data (less data to encryptutilizes less processing resources) and a more efficient and economicalcommunication of the encrypted surgical data (smaller representations ofthe surgical data within the payload of the datagrams allow for moreidentified surgical data to be included in a given datagram, for moreidentified surgical data to be communicated within a given time period,and/or for identified surgical data to be communicated with fewercommunication resources). The component of the surgical hub 206 whichutilizes the compression algorithm can be, for example, the processormodule 232, the processor 244 of the computer system 210, and/orcombinations thereof. The utilized compression algorithm can be alossless compression algorithm or a lossy compression algorithm.

In instances where other non-prioritized surgical data (e.g.,non-failure event surgical data) is to be communicated with prioritizedsurgical data (e.g., failure event surgical data), the othernon-prioritized surgical data can be time-stamped, compressed, and/orencrypted in a manner identical to or different from that describedabove regarding the surgical data identified as associated with afailure event (e.g., failure event surgical data), and the surgical hub206 may be programmed/configured to generate a datagram which includesboth the encrypted prioritized surgical data (e.g., encrypted failureevent surgical data) and the encrypted other non-prioritized surgicaldata (e.g., encrypted non-failure event surgical data). For example, inlight of FIG. 32, the payload 3864 of the datagram 3860 may be dividedinto two or more distinct payload data portions (e.g., one for theprioritized surgical data 3834, one for the non-prioritized surgicaldata 3836), with each portion having an identifying bit (e.g., generatordata (GD) 3866, other data (OD) 3872), the associated encrypted data(e.g., encrypted prioritized surgical data 3868, encryptednon-prioritized surgical data 3874), and the associated padding 3870,3876, if needed, respectively. Further, similar to FIG. 30, the header3862 may be the same as (e.g., IP address source 3878, IP addressdestination 3880, header length 3882) or different from the header 3782described with reference to the datagram 3780 shown in FIG. 29. Forexample, the header 3862 may be different in that the header 3862further includes a field designating the number of payload data portions3884 (e.g., 2) included in the payload 3864 of the datagram 3860. Theheader 3862 can also be different in that it can include fieldsdesignating the payload length 3886, 3890 and the checksum value 3888,2892 for each payload data portion 3834, 3836, respectively. Althoughonly two payload data portions are shown in FIG. 32, it will beappreciated that the payload 3864 of the datagram 3860 may include anyquantity/number of payload data portions (e.g., 1, 2, 3, 4, 5), whereeach payload data portion includes data associated with a differentaspect of the surgical procedure. The datagram 3860 can then becommunicated from the surgical hub 206 through the Internet to thecloud-based system 205 following an IP which: (1) defines datagrams thatencapsulate the encrypted generator data and the encryptedstripped/other data to be delivered, and (2) defines addressing methodsthat are used to label the datagram with source and destinationinformation.

In some aspects, once a failure event associated with a surgicalprocedure has been identified, the surgical hub 206 and/or thecloud-based system 205 can subsequently flag or tag a surgicaldevice/instrument 235 which was utilized during the surgical procedurefor inoperability and/or removal. For example, in one aspect,information (e.g., serial number, ID) associated with the surgicaldevice/instrument 235 and stored at the surgical hub 206 and/or thecloud-based system 205 can be utilized to effectively block the surgicaldevice/instrument 235 from being used again (e.g., blacklisted). Inanother aspect, information (e.g., serial number, ID) associated withthe surgical device/instrument can initiate the printing of a shippingslip and shipping instructions for returning the surgicaldevice/instrument 235 back to a manufacturer or other designated partyso that a thorough analysis/inspection of the surgical device/instrument235 can be performed (e.g., to determine the cause of the failure).According to various aspects described herein, once the cause of afailure is determined (e.g., via the surgical hub 206 and/or thecloud-based system 205), the surgical hub 206 may download a programfrom the cloud-based system 205 for execution by the surgicaldevice/instrument 235 that corrects the determined cause of the failure(i.e., program that alters surgical device/instrument parameters toprevent the failure from occurring again).

According to some aspects, the surgical hub 206 and/or the cloud-basedsystem 205 can also provide/display a reminder (e.g., via hub display215 and/or surgical device/instrument display 237) to administrators,staff, and/or other personnel to physically remove the surgicaldevice/instrument 235 from the operating room (e.g., if detected asstill present in the operating room) and/or to send the surgicaldevice/instrument 235 to the manufacturer or the other designated party.In one aspect, the reminder may be set up to be provided/displayedperiodically until an administrator can remove the flag or tag of thesurgical device/instrument 235 from the surgical hub 206 and/or thecloud-based system 205. According to various aspects, an administratormay remove the flag or tag once the administrator can confirm (e.g.,system tracking of the surgical device/instrument 235 via its serialnumber/ID) that the surgical device/instrument 235 has been received bythe manufacturer or the other designated party. By using theabove-described method to flag and/or track surgical data associatedwith a failure event, a closed loop control of the surgical dataassociated with the failure event and/or with a surgicaldevice/instrument 235 can be realized. Additionally, in view of theabove, it will be appreciated that the surgical hub 206 can be utilizedto effectively manage the utilization (or non-utilization) of surgicaldevices/instruments 235 which have or potentially could be utilizedduring a surgical procedure.

In various aspects of the present disclosure, the surgical hub 206and/or cloud-based system 205 may want to control which components(e.g., surgical device/instrument 235, energy device 241) are beingutilized in its interactive surgical system 100/200 to perform surgicalprocedures (e.g., to minimize future failure events, to avoid the use ofunauthorized or knock-off components).

As such, in various aspects of the present disclosure, since aninteractive surgical system 100 may comprise a plurality of surgicalhubs 106, a cloud-based system 105 and/or each surgical hub 106 of theinteractive surgical system 100 may want to track component-surgical hubcombinations utilized over time. In one aspect, upon/after a component(See FIG. 9, e.g., surgical device/instrument 235, energy device 241) isconnected to/used with a particular surgical hub 106 (e.g., surgicaldevice/instrument 235 wired/wirelessly connected to the particularsurgical hub 106, energy device 241 connected to the particular surgicalhub 106 via generator module 240), the particular surgical hub 106 maycommunicate a record/block of that connection/use (e.g., linkingrespective unique identifiers of the connected devices) to thecloud-based system 105 and/or to the other surgical hubs 106 in theinteractive surgical system 100. For example, upon/after theconnection/use of an energy device 241, a particular surgical hub 106may communicate a record/block (e.g., linking a unique identifier of theenergy device 241 to a unique identifier of a generator module 240 to aunique identifier of the particular surgical hub 106) to the cloud-basedsystem 105 and/or other surgical hubs 106 in the interactive surgicalsystem 100. In such an aspect, if this is the first time the component(e.g., energy device) is connected to/used with a surgical hub 106 inthe interactive surgical system 100, the cloud-based system 105 and/oreach surgical hub 106 of the interactive surgical system 100 may storethe record/block as a genesis record/block. In such an aspect, thegenesis record/block stored at the cloud-based system 105 and/or eachsurgical hub 106 may comprise a time stamp. However, in such an aspect,if this is not the first time the component (e.g., energy device 241)has been connected to/used with a surgical hub 106 in the interactivesurgical system 100, the cloud-based system 105 and/or each surgical hub106 of the interactive surgical system may store the record/block as anew record/block in a chain of record/blocks associated with thecomponent. In such an aspect, the new record/block may comprise acryptographic hash of the most recently communicated record/block storedat the cloud-based system 105 and/or each surgical hub 106, thecommunicated linkage data, and a time stamp. In such an aspect, eachcryptographic hash links each new record/block (e.g., each use of thecomponent) to its prior record/block to form a chain confirming theintegrity of each prior record/block(s) back to an original genesisrecord/block (e.g., first use of the component). According to such anaspect, this blockchain of records/blocks may be developed at thecloud-based system 105 and/or each surgical hub 106 of the interactivesurgical system 100 to permanently and verifiably tie usage of aparticular component to one or more than one surgical hub 106 in theinteractive surgical system 100 over time. Here, according to anotheraspect, this approach may be similarly applied to sub-components (e.g.,handle, shaft, end effector, cartridge) of a component when/after thecomponent is connected to/used with a particular surgical hub 106 of aninteractive surgical system 100.

According to various aspects of the present disclosure, the cloud-basedsystem 105 and/or each surgical hub 106 may utilize such records/blocksto trace usage of a particular component and/or a sub-component back toits initial usage in the interactive surgical system 100. For example,if a particular component (e.g., surgical device/instrument 235) isflagged/tagged as related to a failure event, the cloud-based system 105and/or a surgical hub 106 may analyze such records/blocks to determinewhether past usage of that component and/or a sub-component of thatcomponent contributed to or caused the failure event (e.g., overused).In one example, the cloud-based system 105 may determine that asub-component (e.g., end effector) of that component may actually becontributing/causing the failure event and then tag/flag that componentfor inoperability and/or removal based on the determination.

According to another aspect, the cloud-based system 205 and/or surgicalhub 206 may control which components (e.g., surgical device/instrument235, energy device 241) are being utilized in an interactive surgicalsystem 200 to perform surgical procedures by authenticating thecomponent and/or its supplier/manufacturer. In one aspect, thesupplier/manufacturer of a component may associate a serial number and asource ID with the component. In such an aspect, thesupplier/manufacturer may create/generate a private key for the serialnumber, encrypt the serial number with the private key, and store theencrypted serial number and the source ID on an electronic chip (e.g.,memory) in the component prior to shipment to a surgical site. Here,upon/after connection of the component to a surgical hub 206, thesurgical hub 206 may read the encrypted serial number and the source IDfrom the electronic chip. In response, the surgical hub 206 may send amessage (i.e., comprising the encrypted serial number) to a server ofthe supplier/manufacturer associated with the source ID (e.g., directlyor via the cloud-based system 205). In such an aspect, the surgical hub206 may encrypt the message using a public key associated with thatsupplier/manufacturer. In response, the surgical hub 206 may receive amessage (i.e., comprising the private key the supplier/manufacturergenerated for/associated with that encrypted serial number) from thesupplier/manufacturer server (e.g., directly or via the cloud-basedsystem 205). In such an aspect, the supplier/manufacturer server mayencrypt the message using a public key associated with the surgical hub206. Further, in such an aspect, the surgical hub 206 may then decryptthe message (e.g., using a private key paired to the public key used toencrypt the message) to reveal the private key associated with theencrypted serial number. The surgical hub 206 may then decrypt theencrypted serial number, using that private key, to reveal the serialnumber. Further, in such an aspect, the surgical hub 206 may thencompare the decrypted serial number to a comprehensive list ofauthorized serial numbers (e.g., stored at the surgical hub 206 and/orthe cloud-based system and/or downloaded from the cloud-based system,e.g., received separately from the supplier/manufacturer) and permit useof the connected component if the decrypted serial number matches anauthorized serial number. Initially, such a process permits the surgicalhub 206 to authenticate the supplier/manufacturer. In particular, thesurgical hub 206 encrypted the message comprising the encrypted serialnumber using a public key associated with the supplier/manufacturer. Assuch, receiving a response message (i.e., comprising the private key)authenticates the supplier/manufacturer to the surgical hub 206 (i.e.,otherwise the supplier/manufacturer would not have access to the privatekey paired to the public key used by the surgical hub 206 to encrypt themessage, and the supplier/manufacturer would not have been able toassociate the encrypted serial number received in the message to itsalready generated private key). Furthermore, such a process permits thesurgical hub 206 to authenticate the connected component/device itself.In particular, the supplier/manufacturer (e.g., just authenticated)encrypted the serial number of the component using the delivered privatekey. Upon secure receipt of the private key, the surgical hub 206 isable to decrypt the encrypted serial number (i.e., read from theconnected component), which authenticates the component and/or itsassociation with the supplier/manufacturer (i.e., only that private keyas received from that supplier/manufacturer would decrypt the encryptedserial number). Nonetheless, the surgical hub 206 further verifies thecomponent as authentic (e.g., compares the decrypted serial number to acomprehensive list of authorized serial numbers received separately fromthe supplier/manufacturer). Notably, such aspects as described above canalternatively be performed by the cloud-based system 205 and/or acombination of the cloud-based system 205 and the surgical hub 206 tocontrol which components (e.g., surgical device/instrument 235, energydevice 241) are being utilized in an interactive surgical system 200(e.g., to perform surgical procedures) by authenticating the componentand/or its supplier/manufacturer. In one aspect, such describedapproaches may prevent the use of knock-off component(s) within theinteractive surgical system 200 and ensure the safety and well-being ofsurgical patients.

According to another aspect, the electronic chip of a component (e.g.,surgical device/instrument 235, energy device 241) may store (e.g., inmemory) data associated with usage of that component (i.e., usage data,e.g., number of uses with a limited use device, number of usesremaining, firing algorithms executed, designation as a single-usecomponent). In such an aspect, the surgical hub 206 and/or thecloud-based system 205, upon/after connection of the component to theinteractive surgical system, may read such usage data from the memory ofa component and write back at least a portion of that usage data forstorage (e.g., in memory 249) at the surgical hub 206 and/or for storageat the cloud-based system 205 (e.g., individually and/or under ablockchain approach discussed herein). According to such an aspect, thesurgical hub 206 and/or the cloud-based system 205, upon/after asubsequent connection of that component to the interactive surgicalsystem, may again read such usage data and compare that usage topreviously stored usage data. Here, if a discrepancy exists or if apredetermined/authorized usage has been met, the surgical hub 206 and/orthe cloud-based system 205 may prevent use of that component (e.g.,blacklisted, rendered inoperable, flagged for removal) on theinteractive surgical system 200. In various aspects, such an approachprevents bypass of the encryption chip systems. If the component'selectronic chip/memory has been tampered with (e.g., memory reset,number of uses altered, firing algorithms altered, single-use devicedesignated as a multi-use device), a discrepancy will exist, and thecomponent's use will be controlled/prevented.

Additional details are disclosed in U.S. Patent Application PublicationNo. 2017/0086914, entitled TECHNIQUES FOR OPERATING GENERATOR FORDIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS, which is incorporated herein by reference in its entirety.

Surgical Hub Coordination of Device Pairing in an Operating Room

One of the functions of the surgical hub 106 is to pair (also referredto herein as “connect” or “couple”) with other components of thesurgical system 102 to control, gather information from, or coordinateinteractions between the components of the surgical system 102. Sincethe operating rooms of a hospital are likely in close physical proximityto one another, a surgical hub 106 of a surgical system 102 mayunknowingly pair with components of a surgical system 102 in aneighboring operating room, which would significantly interfere with thefunctions of the surgical hub 106. For example, the surgical hub 106 mayunintentionally activate a surgical instrument in a different operatingroom or record information from a different ongoing surgical procedurein a neighboring operating room.

Aspects of the present disclosure present a solution, wherein a surgicalhub 106 only pairs with detected devices of the surgical system 102 thatare located within the bounds of its operating room.

Furthermore, the surgical hub 106 relies on its knowledge of thelocation of other components of the surgical system 102 within itsoperating room in making decisions about, for example, which surgicalinstruments should be paired with one another or activated. A change inthe position of the surgical hub 106 or another component of thesurgical system 102 can be problematic.

Aspects of the present disclosure further present a solution wherein thesurgical hub 106 is configured to reevaluate or redetermine the boundsof its operating room upon detecting that the surgical hub 106 has beenmoved. Aspects of the present disclosure further present a solutionwherein the surgical hub 106 is configured to redetermine the bounds ofits operating room upon detection of a potential device of the surgicalsystem 102, which can be an indication that the surgical hub 106 hasbeen moved.

In various aspects, a surgical hub 106 is used with a surgical system102 in a surgical procedure performed in an operating room. The surgicalhub 106 comprises a control circuit configured to determine the boundsof the operating room, determine devices of the surgical system 102located within the bounds of the operating room, and pair the surgicalhub 106 with the devices of the surgical system 102 located within thebounds of the operating room.

In one aspect, the control circuit is configured to determine the boundsof the operating room after activation of the surgical hub 106. In oneaspect, the surgical hub 106 includes a communication circuit configuredto detect and pair with the devices of the surgical system locatedwithin the bounds of the operating room. In one aspect, the controlcircuit is configured to redetermine the bounds of the operating roomafter a potential device of the surgical system 102 is detected. In oneaspect, the control circuit is configured to periodically determine thebounds of the operating room.

In one aspect, the surgical hub 106 comprises an operating room mappingcircuit that includes a plurality of non-contact sensors configured tomeasure the bounds of the operating room.

In various aspects, the surgical hub 106 includes a processor and amemory coupled to the processor. The memory stores instructionsexecutable by the processor to pair the surgical hub with devices of thesurgical system 102 located within the bounds of the operating room, asdescribed above. In various aspects, the present disclosure provides anon-transitory computer-readable medium storing computer-readableinstructions which, when executed, cause a machine to pair the surgicalhub 106 with devices of the surgical system 102 located within thebounds of the operating room, as described above.

FIGS. 35 and 36 are logic flow diagrams of processes depicting controlprograms or logic configurations for pairing the surgical hub 106 withdevices of the surgical system 102 located within the bounds of theoperating room, as described above.

The surgical hub 106 performs a wide range of functions that requiresshort- and long-range communication, such as assisting in a surgicalprocedure, coordinating between devices of the surgical system 102, andgathering and transmitting data to the cloud 104. To properly performits functions, the surgical hub 106 is equipped with a communicationmodule 130 capable of short-range communication with other devices ofthe surgical system 102. The communication module 130 is also capable oflong-range communication with the cloud 104.

The surgical hub 106 is also equipped with an operating-room mappingmodule 133 which is capable of identifying the bounds of an operatingroom, and identifying devices of the surgical system 102 within theoperating room. The surgical hub 106 is configured to identify thebounds of an operating room, and only pair with or connect to potentialdevices of the surgical system 102 that are detected within theoperating room.

In one aspect, the pairing comprises establishing a communication linkor pathway. In another aspect, the pairing comprises establishing acontrol link or pathway.

An initial mapping or evaluation of the bounds of the operating roomtakes place during an initial activation of the surgical hub 106.Furthermore, the surgical hub 106 is configured to maintain spatialawareness during operation by periodically mapping its operating room,which can be helpful in determining if the surgical hub 106 has beenmoved. The reevaluation 3017 can be performed periodically or it can betriggered by an event such as observing a change in the devices of thesurgical system 102 that are deemed within the operating room. In oneaspect, the change is detection 3010 of a new device that was notpreviously deemed as within the bounds of the operating room, asillustrated in FIG. 37. In another aspect, the change is adisappearance, disconnection, or un-pairing of a paired device that waspreviously deemed as residing within the operating room, as illustratedin FIG. 38. The surgical hub 106 may continuously monitor 3035 theconnection with paired devices to detect 3034 the disappearance,disconnection, or un-pairing of a paired device.

In other aspects, reevaluation triggering events can be, for example,changes in surgeons' positions, instrument exchanges, or sensing of anew set of tasks being performed by the surgical hub 106.

In one aspect, the evaluation of the bounds of the room by the surgicalhub 106 is accomplished by activation of a sensor array of theoperating-room mapping module 133 within the surgical hub 106 whichenables it to detect the walls of the operating room.

Other components of the surgical system 102 can be made to be spatiallyaware in the same, or a similar, manner as the surgical hub 106. Forexample, a robotic hub 122 may also be equipped with an operating-roommapping module 133.

The spatial awareness of the surgical hub 106 and its ability to map anoperating room for potential components of the surgical system 102allows the surgical hub 106 to make autonomous decisions about whetherto include or exclude such potential components as part of the surgicalsystem 102, which relieves the surgical staff from dealing with suchtasks. Furthermore, the surgical hub 106 is configured to makeinferences about, for example, the type of surgical procedure to beperformed in the operating room based on information gathered prior to,during, and/or after the performance of the surgical procedure. Examplesof gathered information include the types of devices that are broughtinto the operating room, time of introduction of such devices into theoperating room, and/or the devices sequence of activation.

In one aspect, the surgical hub 106 employs the operating-room mappingmodule 133 to determine the bounds of the surgical theater (e.g., afixed, mobile, or temporary operating room or space) using eitherultrasonic or laser non-contact measurement devices.

Referring to FIG. 34, ultrasound based non-contact sensors 3002 can beemployed to scan the operating theater by transmitting a burst ofultrasound and receiving the echo when it bounces off a perimeter wall3006 of an operating theater to determine the size of the operatingtheater and to adjust Bluetooth pairing distance limits. In one example,the non-contact sensors 3002 can be Ping ultrasonic distance sensors, asillustrated in FIG. 34.

FIG. 34 shows how an ultrasonic sensor 3002 sends a brief chirp with itsultrasonic speaker 3003 and makes it possible for a micro-controller3004 of the operating-room mapping module 133 to measure how long theecho takes to return to the ultrasonic sensor's ultrasonic microphone3005. The micro-controller 3004 has to send the ultrasonic sensor 3002 apulse to begin the measurement. The ultrasonic sensor 3002 then waitslong enough for the micro-controller program to start a pulse inputcommand. Then, at about the same time the ultrasonic sensor 3002 chirpsa 40 kHz tone, it sends a high signal to the micro-controller 3004. Whenthe ultrasonic sensor 3002 detects the echo with its ultrasonicmicrophone 3005, it changes that high signal back to low. Themicro-controller's pulse input command measures the time between thehigh and low changes and stores its measurement in a variable. Thisvalue can be used along with the speed of sound in air to calculate thedistance between the surgical hub 106 and the operating-room wall 3006.

In one example, as illustrated in FIG. 33, a surgical hub 106 can beequipped with four ultrasonic sensors 3002, wherein each of the fourultrasonic sensors is configured to assess the distance between thesurgical hub 106 and a wall of the operating room 3000. A surgical hub106 can be equipped with more or less than four ultrasonic sensors 3002to determine the bounds of an operating room.

Other distance sensors can be employed by the operating-room mappingmodule 133 to determine the bounds of an operating room. In one example,the operating-room mapping module 133 can be equipped with one or morephotoelectric sensors that can be employed to assess the bounds of anoperating room. In one example, suitable laser distance sensors can alsobe employed to assess the bounds of an operating room. Laser-basednon-contact sensors may scan the operating theater by transmitting laserlight pulses, receiving laser light pulses that bounce off the perimeterwalls of the operating theater, and comparing the phase of thetransmitted pulse to the received pulse to determine the size of theoperating theater and to adjust Bluetooth pairing distance limits.

Referring to the top left corner of FIG. 33, a surgical hub 106 isbrought into an operating room 3000. The surgical hub 106 is activatedat the beginning of the set-up that occurs prior to the surgicalprocedure. In the example of FIG. 33, the set-up starts at an actualtime of 11:31:14 (EST) based on a real-time clock. However, at thestated procedure set-up start time, the surgical hub 106 starts 3001 anartificial randomized real-time clock timing scheme at artificial realtime 07:36:00 to protect private patient information.

At artificial real time 07:36:01, the operating-room mapping module 133employs the ultrasonic distance sensors to ultrasonically ping the room(e.g., sends out a burst of ultrasound and listens for the echo when itbounces off the perimeter walls of the operating room as describedabove) to verify the size of the operating room and to adjust pairingdistance limits.

At artificial real time 07:36:03, the data is stripped and time-stamped.At artificial real time 07:36:05, the surgical hub 106 begins pairingdevices located only within the operating room 3000 as verified usingultrasonic distance sensors 3002 of the operating-room mapping module133. The top right corner of FIG. 33 illustrates several example devicesthat are within the bounds of the operating room 3000 and are pairedwith the surgical hub 106, including a secondary display device 3020, asecondary hub 3021, a common interface device 3022, a powered stapler3023, a video tower module 3024, and a powered handheld dissector 3025.On the other hand, secondary hub 3021′, secondary display device 3020′,and powered stapler 3026 are all outside the bounds of the operatingroom 3000 and, accordingly, are not paired with the surgical hub 106.

In addition to establishing a communication link with the devices of thesurgical system 102 that are within the operating room, the surgical hub106 also assigns a unique identification and communication sequence ornumber to each of the devices. The unique sequence may include thedevice's name and a time stamp of when the communication was firstestablished. Other suitable device information may also be incorporatedinto the unique sequence of the device.

As illustrated in the top left corner of FIG. 33, the surgical hub 106has determined that the operating room 3000 bounds are at distances a,−a, b, and −b from the surgical hub 106. Since Device “D” is outside thedetermined bounds of its operating room 3000, the surgical hub 106 willnot pair with the Device “D.” FIG. 35 is an example algorithmillustrating how the surgical hub 106 only pairs with devices within thebounds of its operating room. After activation, the surgical hub 106determines 3007 bounds of the operating room using the operating-roommapping module 133, as described above. After the initial determination,the surgical hub 106 continuously searches for or detects 3008 deviceswithin a pairing range. If a device is detected 3010, the surgical hub106 then determines 3011 whether the detected device is within thebounds of the operating room. The surgical hub 106 pairs 3012 with thedevice if it is determined that the device is within the bounds of theoperating room. In certain instances, the surgical hub 106 will alsoassign 3013 an identifier to the device. If, however, the surgical hub106 determines that the detected device is outside the bounds of theoperating room, the surgical hub 106 will ignore 3014 the device.

Referring to FIG. 36, after an initial determination of the bounds ofthe room, and after an initial pairing of devices located within suchbounds, the surgical hub 106 continues to detect 3015 new devices thatbecome available for pairing. If a new device is detected 3016, thesurgical hub 106 is configured to reevaluate 3017 the bounds of theoperating room prior to pairing with the new device. If the new deviceis determined 3018 to be within the newly determined bounds of theoperating room, then the surgical hub 106 pairs with the device 3019 andassigns 3030 a unique identifier to the new device. If, however, thesurgical hub 106 determines that the new device is outside the newlydetermined bounds of the operating room, the surgical hub 106 willignore 3031 the device.

For pairing, the operating-room mapping module 133 contains a compassand integrated Bluetooth transceiver. Other communication mechanisms,which are not significantly affected by the hospital environment orgeographical location, can be employed. Bluetooth Low Energy (BLE)beacon technology can currently achieve indoor distance measurementswith accuracy of about 1-2 meters, with improved accuracy in closerproximities (within 0-6 meters). To improve the accuracy of the distancemeasurements, a compass is used with the BLE. The operating-room mappingmodule 133 utilizes the BLE and the compass to determine where modulesare located in relation to the patient. For example, two modules facingeach other (detected by compass) with greater than one meter distancebetween them may clearly indicate that the modules are on opposite sidesof the patient. The more “Hub”-enabled modules that reside in theoperating room, the greater the achievable accuracy becomes due totriangulation techniques.

In the situations where multiple surgical hubs 106, modules, and/orother peripherals are present in the same operating room, as illustratedin the top right corner of FIG. 33, the operating-room mapping module133 is configured to map the physical location of each module thatresides within the operating room. This information could be used by theuser interface to display a virtual map of the room, enabling the userto more easily identify which modules are present and enabled, as wellas their current status. In one aspect, the mapping data collected bysurgical hubs 106 are uploaded to the cloud 104, where the data areanalyzed for identifying how an operating room is physically setup, forexample.

The surgical hub 106 is configured to determine a device's location byassessing transmission radio signal strength and direction. ForBluetooth protocols, the Received Signal Strength Indication (RSSI) is ameasurement of the received radio signal strength. In one aspect, thedevices of the surgical system 102 can be equipped with USB Bluetoothdongles. The surgical hub 106 may scan the USB Bluetooth beacons to getdistance information. In another aspect, multiple high-gain antennas ona Bluetooth access point with variable attenuators can produce moreaccurate results than RSSI measurements. In one aspect, the hub isconfigured to determine the location of a device by measuring the signalstrength from multiple antennas. Alternatively, in some examples, thesurgical hub 106 can be equipped with one or more motion sensor devicesconfigured to detect a change in the position of the surgical hub 106.

Referring to the bottom left corner of FIG. 33, the surgical hub 106 hasbeen moved from its original position, which is depicted in dashedlines, to a new position closer to the device “D,” which is stilloutside the bounds of the operating room 3000. The surgical hub 106 inits new position, and based on the previously determined bounds of theoperating room, would naturally conclude that the device “D” is apotential component of the surgical system 102. However, theintroduction of a new device is a triggering event for reevaluation 3017of the bounds of the operating room, as illustrated in the examplealgorithm of FIGS. 35, 37. After performing the reevaluation, thesurgical hub 106 determines that the operating room bounds have changed.Based on the new bounds, at distances a_(new), −a_(new), b_(new), and−b_(new), the surgical hub 106 concludes that it has been moved and thatthe Device “D” is outside the newly determined bounds of its operatingroom. Accordingly, the surgical hub 106 will still not pair with theDevice “D.”

In one aspect, one or more of the processes depicted in FIGS. 35-39 canbe executed by a control circuit of a surgical hub 106, as depicted inFIG. 10 (processor 244). In another aspect, one or more of the processesdepicted in FIGS. 35-39 can be executed by a cloud computing system 104,as depicted in FIG. 1. In yet another aspect, one or more of theprocesses depicted in FIGS. 35-39 can be executed by at least one of theaforementioned cloud computing systems 104 and/or a control circuit of asurgical hub 106 in combination with a control circuit of a modulardevice, such as the microcontroller 461 of the surgical instrumentdepicted in FIG. 12, the microcontroller 620 of the surgical instrumentdepicted in FIG. 16, the control circuit 710 of the robotic surgicalinstrument 700 depicted in FIG. 17, the control circuit 760 of thesurgical instruments 750, 790 depicted in FIGS. 18-19, or the controller838 of the generator 800 depicted in FIG. 20.

Spatial Awareness of Surgical Hubs in Operating Rooms

During a surgical procedure, a surgical instrument such as an ultrasonicor an RF surgical instrument can be coupled to a generator module 140 ofthe surgical hub 106. In addition, a separate surgical instrumentcontroller such as a foot, or hand, switch or activation device can beused by an operator of the surgical instrument to activate the energyflow from the generator to the surgical instrument. Multiple surgicalinstrument controllers and multiple surgical instruments can be usedconcurrently in an operating room. Pressing or activating the wrongsurgical instrument controller can lead to undesirable consequences.Aspects of the present disclosure present a solution in which thesurgical hub 106 coordinates the pairing of surgical instrumentcontrollers and surgical instruments to ensure patient and operatorsafety.

Aspects of the present disclosure are presented for a surgical hub 106configured to establish and sever pairings between components of thesurgical system 102 within the bounds of the operating room tocoordinate flow of information and control actions between suchcomponents. The surgical hub 106 can be configured to establish apairing between a surgical instrument controller and a surgicalinstrument that reside within the bounds of an operating room ofsurgical hub 106.

In various aspects, the surgical hub 106 can be configured to establishand sever pairings between components of the surgical system 102 basedon operator request or situational and/or spatial awareness. The hubsituational awareness is described in greater detail below in connectionwith FIG. 62.

Aspects of the present disclosure are presented for a surgical hub foruse with a surgical system in a surgical procedure performed in anoperating room. The surgical hub includes a control circuit thatselectively forms and severs pairings between devices of the surgicalsystem. In one aspect, the hub includes a control circuit is configuredto pair the hub with a first device of the surgical system, assign afirst identifier to the first device, pair the hub with a second deviceof the surgical system, assign a second identifier to the second device,and selectively pair the first device with the second device. In oneaspect, the surgical hub includes a storage medium, wherein the controlcircuit is configured to store a record indicative of the pairingbetween the first device and the second device in the storage medium. Inone aspect, the pairing between the first device and the second devicedefines a communication pathway therebetween. In one aspect, the pairingbetween the first device and the second device defines a control pathwayfor transmitting control actions from the second device to the firstdevice.

Further to the above, in one aspect, the control circuit is furtherconfigured to pair the hub with a third device of the surgical system,assign a third identifier to the third device, sever the pairing betweenthe first device and the second device, and selectively pair the firstdevice with the third device. In one aspect, the control circuit isfurther configured to store a record indicative of the pairing betweenthe first device and the third device in the storage medium. In oneaspect, the pairing between the first device and the third devicedefines a communication pathway therebetween. In one aspect, the pairingbetween the first device and the third device defines a control pathwayfor transmitting control actions from the third device to the firstdevice.

In various aspects, the surgical hub includes a processor and a memorycoupled to the processor. The memory stores instructions executable bythe processor to selectively form and sever pairings between the devicesof the surgical system, as described above. In various aspects, thepresent disclosure provides a non-transitory computer-readable mediumstoring computer-readable instructions which, when executed, cause amachine to selectively form and sever pairings between the devices ofthe surgical system, as described above. FIGS. 40 and 41 are logic flowdiagrams of processes depicting control programs or logic configurationsfor selectively forming and severing pairings between the devices of thesurgical system, as described above.

In one aspect, the surgical hub 106 establishes a first pairing with asurgical instrument and a second pairing with the surgical instrumentcontroller. The surgical hub 106 then links the pairings togetherallowing the surgical instrument and the surgical instrument controllerto operate with one another. In another aspect, the surgical hub 106 maysever an existing communication link between a surgical instrument and asurgical instrument controller, then link the surgical instrument toanother surgical instrument controller that is linked to the surgicalhub 106.

In one aspect, the surgical instrument controller is paired to twosources. First, the surgical instrument controller is paired to thesurgical hub 106, which includes the generator module 140, for controlof its activation. Second, the surgical instrument controller is alsopaired to a specific surgical instrument to prevent inadvertentactivation of the wrong surgical instrument.

Referring to FIGS. 40 and 42, the surgical hub 106 may cause thecommunication module 130 to pair 3100 or establish a first communicationlink 3101 with a first device 3102 of the surgical system 102, which canbe a first surgical instrument. Then, the hub may assign 3104 a firstidentification number to the first device 3102. This is a uniqueidentification and communication sequence or number that may include thedevice's name and a time stamp of when the communication was firstestablished.

In addition, the surgical hub 106 may then cause the communicationmodule 130 to pair 3106 or establish a second communication link 3107with a second device 3108 of the surgical system 102, which can be asurgical instrument controller. The surgical hub 106 then assigns 3110 asecond identification number to the second device 3108.

In various aspects, the steps of pairing a surgical hub 106 with adevice may include detecting the presence of a new device, determiningthat the new device is within bounds of the operating room, as describedabove in greater detail, and only pairing with the new device if the newdevice is located within the bounds of the operating room.

The surgical hub 106 may then pair 3112 or authorize a communicationlink 3114 to be established between the first device 3102 and the seconddevice 3108, as illustrated in FIG. 42. A record indicative of thecommunication link 3114 is stored by the surgical hub 106 in the storagearray 134. In one aspect, the communication link 3114 is establishedthrough the surgical hub 106. In another aspect, as illustrated in FIG.42, the communication link 3114 is a direct link between the firstdevice 3102 and the second device 3108.

Referring to FIGS. 41 and 43, the surgical hub 106 may then detect andpair 3120 or establish a third communication link 3124 with a thirddevice 3116 of the surgical system 102, which can be another surgicalinstrument controller, for example. The surgical hub 106 may then assign3126 a third identification number to the third device 3116.

In certain aspects, as illustrated in FIG. 43, the surgical hub 106 maythen pair 3130 or authorize a communication link 3118 to be establishedbetween the first device 3102 and the third device 3116, while causingthe communication link 3114 to be severed 3128, as illustrated in FIG.43. A record indicative of the formation of the communication link 3118and severing of the communication link 3114 is stored by the surgicalhub 106 in the storage array 134. In one aspect, the communication link3118 is established through the surgical hub 106. In another aspect, asillustrated in FIG. 43, the communication link 3118 is a direct linkbetween the first device 3102 and the third device 3116.

As described above, the surgical hub 106 can manage an indirectcommunication between devices of the surgical system 102. For example,in situations where the first device 3102 is a surgical instrument andthe second device 3108 is a surgical instrument controller, an output ofthe surgical instrument controller can be transmitted through thecommunication link 3107 to the surgical hub 106, which may then transmitthe output to the surgical instrument through the communication link3101.

In making a decision to connect or sever a connection between devices ofthe surgical system 102, the surgical hub 106 may rely on perioperativedata received or generated by the surgical hub 106. Perioperative dataincludes operator input, hub-situational awareness, hub-spatialawareness, and/or cloud data. For example, a request can be transmittedto the surgical hub 106 from an operator user-interface to assign asurgical instrument controller to a surgical instrument. If the surgicalhub 106 determines that the surgical instrument controller is alreadyconnected to another surgical instrument, the surgical hub 106 may severthe connection and establish a new connection per the operator'srequest.

In certain examples, the surgical hub 106 may establish a firstcommunication link between the visualization system 108 and the primarydisplay 119 to transmit an image, or other information, from thevisualization system 108, which resides outside the sterile field, tothe primary display 119, which is located within the sterile field. Thesurgical hub 106 may then sever the first communication link andestablish a second communication link between a robotic hub 122 and theprimary display 119 to transmit another image, or other information,from the robotic hub 122 to the primary display 119, for example. Theability of the surgical hub 106 to assign and reassign the primarydisplay 119 to different components of the surgical system 102 allowsthe surgical hub 106 to manage the information flow within the operatingroom, particularly between components inside the sterile field andoutside the sterile field, without physically moving these components.

In another example that involves the hub-situational awareness, thesurgical hub 106 may selectively connect or disconnect devices of thesurgical system 102 within an operating room based on the type ofsurgical procedure being performed or based on a determination of anupcoming step of the surgical procedure that requires the devices to beconnected or disconnected. The hub situational awareness is described ingreater detail below in connection with FIG. 62.

Referring to FIG. 44, the surgical hub 106 may track 3140 theprogression of surgical steps in a surgical procedure and may coordinatepairing and unpairing of the devices of the surgical system 102 basedupon such progression. For example, the surgical hub 106 may determinethat a first surgical step requires use of a first surgical instrument,while a second surgical step, occurring after completion of the firstsurgical step, requires use of a second surgical instrument.Accordingly, the surgical hub 106 may assign a surgical instrumentcontroller to the first surgical instrument for the duration of thefirst surgical step. After detecting completion 3142 of the firstsurgical step, the surgical hub 106 may cause the communication linkbetween the first surgical instrument and the surgical instrumentcontroller to be severed 3144. The surgical hub 106 may then assign thesurgical instrument controller to the second surgical instrument bypairing 3146 or authorizing the establishment of a communication linkbetween the surgical instrument controller and the second surgicalinstrument.

Various other examples of the hub-situational awareness, which caninfluence the decision to connect or disconnect devices of the surgicalsystem 102, are described in greater detail below in connection withFIG. 62.

In certain aspects, the surgical hub 106 may utilize its spatialawareness capabilities, as described in greater detail elsewhere herein,to track progression of the surgical steps of a surgical procedure andautonomously reassign a surgical instrument controller from one surgicalinstrument to another surgical instrument within the operating room ofthe surgical hub 106. In one aspect, the surgical hub 106 uses Bluetoothpairing and compass information to determine the physical position ofthe components of the surgical system 102.

In the example illustrated in FIG. 2, the surgical hub 106 is pairedwith a first surgical instrument held by a surgical operator at theoperating table and a second surgical instrument positioned on a sidetray. A surgical instrument controller can be selectively paired witheither the first surgical instrument or the second surgical instrument.Utilizing the Bluetooth pairing and compass information, the surgicalhub 106 autonomously assigns the surgical instrument controller to thefirst surgical instrument because of its proximity to the patient.

After completion of the surgical step that involved using the firstsurgical instrument, the first surgical instrument may be returned tothe side tray or otherwise moved away from the patient. Detecting achange in the position of the first surgical instrument, the surgicalhub 106 may sever the communication link between the first surgicalinstrument and the surgical instrument controller to protect againstunintended activation of the first surgical instrument by the surgicalinstrument controller. The surgical hub 106 may also reassign thesurgical instrument controller to another surgical instrument if thesurgical hub 106 detects that it has been moved to a new position at theoperating table.

In various aspects, devices of the surgical system 102 are equipped withan easy hand-off operation mode that would allow one user to giveactivation control of a device they currently control to anothersurgical instrument controller within reach of another operator. In oneaspect, the devices are equipped to accomplish the hand-off through apredetermined activation sequence of the devices that causes the devicesthat are activated in the predetermined activation sequence to pair withone another.

In one aspect, the activation sequence is accomplished by powering onthe devices to be paired with one another in a particular order. Inanother aspect, the activation sequence is accomplished by powering onthe devices to be paired with one another within a predetermined timeperiod. In one aspect, the activation sequence is accomplished byactivating communication components, such as Bluetooth, of the devicesto be paired with one another in a particular order. In another aspect,the activation sequence is accomplished by activating communicationcomponents, such as Bluetooth, of the devices to be paired within oneanother within a predetermined time period.

Alternatively, the hand-off can also be accomplished by a selection of adevice through one of the surgical-operator input devices. After theselection is completed, the next activation by another controller wouldallow the new controller to take control.

In various aspects, the surgical hub 106 can be configured to directlyidentify components of the surgical system 102 as they are brought intoan operating room. In one aspect, the devices of the surgical system 102can be equipped with an identifier recognizable by the surgical hub 106,such as, for example, a bar code or an RFID tag. NFC can also beemployed. The surgical hub 106 can be equipped with a suitable reader orscanner for detecting the devices brought into the operating room.

The surgical hub 106 can also be configured to check and/or updatevarious control programs of the devices of the surgical system 102. Upondetecting and establishing a communication link of a device of thesurgical system 102, the surgical hub 106 may check if its controlprogram is up to date. If the surgical hub 106 determines that a laterversion of the control program is available, the surgical hub 106 maydownload the latest version from the cloud 104 and may update the deviceto the latest version. The surgical hub 106 may issue a sequentialidentification and communication number to each paired or connecteddevice.

Cooperative Utilization of Data Derived from Secondary Sources byIntelligent Surgical Hubs

In a surgical procedure, the attention of a surgical operator must befocused on the tasks at hand. Receiving information from multiplesources, such as, for example, multiple displays, although helpful, canalso be distracting. The imaging module 138 of the surgical hub 106 isconfigured to intelligently gather, analyze, organize/package, anddisseminate relevant information to the surgical operator in a mannerthat minimizes distractions.

Aspects of the present disclosure are presented for cooperativeutilization of data derived from multiple sources, such as, for example,an imaging module 138 of the surgical hub 106. In one aspect, theimaging module 138 is configured to overlay data derived from one ormore sources onto a livestream destined for the primary display 119, forexample. In one aspect, the overlaid data can be derived from one ormore frames acquired by the imaging module 138. The imaging module 138may commandeer image frames on their way for display on a local displaysuch as, for example, the primary display 119. The imaging module 138also comprises an image processor that may preform an array of localimage processing on the commandeered images.

Furthermore, a surgical procedure generally includes a number ofsurgical tasks which can be performed by one or more surgicalinstruments guided by a surgical operator or a surgical robot, forexample. Success or failure of a surgical procedure depends on thesuccess or failure of each of the surgical tasks. Without relevant dataon the individual surgical tasks, determining the reason for a failedsurgical procedure is a question of probability.

Aspects of the present disclosure are presented for capturing one ormore frames of a livestream of a surgical procedure for furtherprocessing and/or pairing with other data. The frames may be captured atthe completion of a surgical task (also referred to elsewhere herein as“surgical step”) to assess whether the surgical task was completedsuccessfully. Furthermore, the frames, and the paired data, can beuploaded to the cloud for further analysis.

In one aspect, one or more captured images are used to identify at leastone previously completed surgical task to evaluate the outcome of thesurgical task. In one aspect, the surgical task is a tissue-staplingtask. In another aspect, the surgical task is an advanced energytransection.

FIG. 45 is a logic flow diagram of a process 3210 depicting a controlprogram or a logic configuration for overlaying information derived fromone or more still frames of a livestream of a remote surgical site ontothe livestream. The process 3210 includes receiving 3212 a livestream ofa remote surgical site from a medical imaging device 124, for example,capturing 3214 at least one image frame of a surgical step of thesurgical procedure from the livestream, deriving 3216 informationrelevant to the surgical step from data extracted from the at least oneimage frame, and overlaying 3218 the information onto the livestream.

In one aspect, the still frames can be of a surgical step performed atthe remote surgical site. The still frames can be analyzed forinformation regarding completion of the surgical step. In one aspect,the surgical step comprises stapling tissue at the surgical site. Inanother aspect, the surgical task comprises applying energy to tissue atthe surgical site.

FIG. 46 is a logic flow diagram of a process 3220 depicting a controlprogram or a logic configuration for differentiating among surgicalsteps of a surgical procedure. The process 3220 includes receiving 3222a livestream of a surgical site from a medical imaging device 124, forexample, capturing 3224 at least one first image frame of a firstsurgical step of the surgical procedure from the livestream, deriving3226 information relevant to the first surgical step from data extractedfrom the at least one image frame, capturing 3228 at least one secondimage frame of a second surgical step of the surgical procedure from thelivestream, and differentiating 3229 among the first surgical step andthe second surgical step based on the at least one first image frame andthe at least one second image frame.

FIG. 47 is a logic flow diagram of a process 3230 depicting a controlprogram or a logic configuration for differentiating among surgicalsteps of a surgical procedure. The process 3232 includes receiving 3232a livestream of the surgical site from a medical imaging device 124, forexample, capturing 3234 image frames of the surgical steps of thesurgical procedure from the livestream and differentiating 3236 amongthe surgical steps based on data extracted from the image frames.

FIG. 48 is a logic flow diagram of a process 3240 depicting a controlprogram or a logic configuration for identifying a staple cartridge frominformation derived from one or more still frames of staples deployedfrom the staple cartridge into tissue. The process 3240 includesreceiving 3242 a livestream of the surgical site from medical imagingdevice 124, for example, capturing 3244 an image frame from thelivestream, detecting 3246 a staple pattern in the image frame, whereinthe staple pattern is defined by staples deployed from a staplecartridge into tissue at the surgical site. The process 3240 furtherincludes identifying 3248 the staple cartridge based on the staplepattern.

In various aspects, one or more of the steps of the processes 3210,3220, 3230, 3240 can be executed by a control circuit of an imagingmodule of a surgical hub, as depicted in FIGS. 3, 9, 10. In certainexamples, the control circuit may include a processor and a memorycoupled to the processor, wherein the memory stores instructionsexecutable by the processor to perform one or more of the steps of theprocesses 3210, 3220, 3230, 3240. In certain examples, a non-transitorycomputer-readable medium stores computer-readable instructions which,when executed, cause a machine to perform one or more of the steps ofthe processes 3210, 3220, 3230, 3240. For economy, the followingdescription of the processes 3210, 3220, 3230, 3240 will be described asbeing executed by the control circuit of an imaging module of a surgicalhub; however, it should be understood that the execution of theprocesses 3210, 3220, 3230, 3240 can be accomplished by any of theaforementioned examples.

Referring to FIGS. 34 and 49, a surgical hub 106 is in communicationwith a medical imaging device 124 located at a remote surgical siteduring a surgical procedure. The imaging module 138 receives alivestream of the remote surgical site transmitted by the imaging device124 to a primary display 119, for example, in accordance with steps3212, 3222, 3232, 3242.

Further to the above, the imaging module 138 of the surgical hub 106includes a frame grabber 3200. The frame grabber 3200 is configured tocapture (i.e., “grabs”) individual, digital still frames from thelivestream transmitted by the imaging device 124, for example, to aprimary display 119, for example, during a surgical procedure, inaccordance with steps 3214, 3224, 3234, 3244. The captured still framesare stored and processed by a computer platform 3203 (FIG. 49) of theimaging module 138 to derive information about the surgical procedure.Processing of the captured frames may include performance of simpleoperations, such as histogram calculations, 2D filtering, and arithmeticoperations on arrays of pixels to the performance of more complex tasks,such as object detection, 3D filtering, and the like.

In one aspect, the derived information can be overlaid onto thelivestream. In one aspect, the still frames and/or the informationresulting from processing the still frames can be communicated to acloud 104 for data aggregation and further analysis.

In various aspects, the frame grabber 3200 may include a digital videodecoder and a memory for storing the acquired still frames, such as, forexample, a frame buffer. The frame grabber 3200 may also include a businterface through which a processor can control the acquisition andaccess the data and a general purpose I/O for triggering imageacquisition or controlling external equipment.

As described above, the imaging device 124 can be in the form of anendoscope, including a camera and a light source positioned at a remotesurgical site, and configured to provide a livestream of the remotesurgical site at the primary display 119, for example.

In various aspects, image recognition algorithms can be implemented toidentify features or objects in still frames of a surgical site that arecaptured by the frame grabber 3200. Useful information pertaining to thesurgical steps associated with the captured frames can be derived fromthe identified features. For example, identification of staples in thecaptured frames indicates that a tissue-stapling surgical step has beenperformed at the surgical site. The type, color, arrangement, and sizeof the identified staples can also be used to derive useful informationregarding the staple cartridge and the surgical instrument employed todeploy the staples. As described above, such information can be overlaidon a livestream directed to a primary display 119 in the operating room.

The image recognition algorithms can be performed at least in partlocally by the computer platform 3203 (FIG. 49) of the imaging module138. In certain instances, the image recognition algorithms can beperformed at least in part by the processor module 132 of the surgicalhub 106. An image database can be utilized in performance of the imagerecognition algorithms and can be stored in a memory 3202 of thecomputer platform 3203. Alternatively, the imaging database can bestored in the storage array 134 (FIG. 3) of the surgical hub 106. Theimage database can be updated from the cloud 104.

An example image recognition algorithm that can be executed by thecomputer platform 3203 may include a key points-based comparison and aregion-based color comparison. The algorithm includes: receiving aninput at a processing device, such as, for example, the computerplatform 3203; the input, including data related to a still frame of aremote surgical site; performing a retrieving step, including retrievingan image from an image database and, until the image is either acceptedor rejected, designating the image as a candidate image; performing animage recognition step, including using the processing device to performan image recognition algorithm on the still frame and candidate imagesin order to obtain an image recognition algorithm output; and performinga comparison step, including: if the image recognition algorithm outputis within a pre-selected range, accepting the candidate image as thestill frame and if the image recognition algorithm output is not withinthe pre-selected range, rejecting the candidate image and repeating theretrieving, image recognition, and comparison steps.

Referring to FIGS. 50-52, in one example, a surgical step involvesstapling and cutting tissue. FIG. 50 depicts a still frame 3250 of astapled and cut tissue T. A staple deployment 3252 includes staples3252′, 3252″ from a first staple cartridge. A second staple deployment3254 includes staples 3254′, 3254″ from a second staple cartridge. Aproximal portion 3253 of the staple deployment 3252 overlaps with adistal portion 3255 of the staple deployment 3254. Six rows of stapleswere deployed in each deployment. Tissue T was cut between the third andfourth rows of each deployment, but only one side of the stapled tissueT is fully shown.

In various aspects, the imaging module 138 identifies one or more of thestaples 3252′, 3252″, 3254′, 3254″ in the still frame 3250, which wereabsent in a previous still frame captured by the frame grabber 3200. Theimaging module 138 then concludes that a surgical stapling and cuttinginstrument has been used at the surgical site.

In the example of FIG. 50, the staple deployment 3252 includes twodifferent staples 3252′, 3252″. Likewise, the staple deployment 3254includes two different staples 3254′, 3254″. For brevity, the followingdescription focuses on the staples 3252′, 3252″, but is equallyapplicable to the staples 3254′, 3254″. The staples 3252′, 3252″ arearranged in a predetermined pattern or sequence that forms a uniqueidentifier corresponding to the staple cartridge that housed the staples3252′, 3252″. The unique pattern can be in a single row or multiple rowsof the staples 3250. In one example, the unique pattern can be achievedby alternating the staples 3252′, 3252″ at a predetermined arrangement.

In one aspect, multiple patterns can be detected in a firing of staples.Each pattern can be associated with a unique characteristic of thestaples, the staple cartridge that housed the staples, and/or thesurgical instrument that was employed to fire the staple. For example, afiring of staples may include patterns that represent staple form,staple size, and/or location of the firing.

In the example, of FIG. 50, the imaging module 138 may identify a uniquepattern of the staples 3252 from the still frame 3250. A databasestoring staple patterns and corresponding identification numbers ofstaple cartridges can then be explored to determine an identificationnumber of a staple cartridge that housed the staples 3252.

The patterns of the example of FIG. 50 are based on only two differentstaples; however, other aspects may include three or more differentstaples. The different staples can be coated with different coatings,which can be applied to the staples by one or more of the followingmethods: anodizing, dying, electro-coating, photoluminescent coating,application of nitrides, methyl methacylate, painting, powder coating,coating with paraffins, oil stains or phosphor coatings, the use ofhydroxyapatite, polymers, titanium oxinitrides, zinc sulfides, carbides,etc. It should be noted that, while the listed coatings are fairlyspecific as disclosed herein, other coatings known in the art todistinguish the staple are within the contemplated scope of the presentdisclosure.

In the example of FIGS. 50-52, the staples 3252′ are anodized staples,while the staples 3252″ are non-anodized staples. In one aspect, thedifferent staples may comprise two or more different colors. Differentmetal staples may comprise magnetic or radioactive staple markers thatdifferentiate them from unmarked staples.

FIG. 51 illustrates a staple deployment 3272 deployed into tissue from astaple cartridge via a surgical instrument. Only three staple rows 3272a, 3272 b, 3272 c are depicted in FIG. 51. The rows 3272 a, 3272 b, 3272c are arranged between a medial line, where the tissue was cut, and alateral line at the tissue edge. For clarity, the inner row 3272 a ofstaples is redrawn separately to the left and the outer two rows 3272 b,3272 c are redrawn separately to the right. A proximal end 3273 and adistal end portion of the staple deployment 3272 are also redrawn inFIG. 51 for clarity.

The staple deployment 3272 includes two different staples 3272′, 3272″that are arranged in predetermined patterns that serve variousfunctions. For example, the inner row 3272 a comprises a pattern ofalternating staples 3272′, 3272″, which defines a metric for distancemeasurements in the surgical field. In other words, the pattern of theinner row 3272 a acts as a ruler for measuring distances, which can behelpful in accurately determining the position of a leak, for example.The outer rows 3272 b, 3272 c define a pattern that represents anidentification number of the staple cartridge that housed the staples3272′, 3272″.

Furthermore, unique patterns at the ends of the staple deployment 3272identify the proximal end portion 3273 and distal end portion 3275. Inthe example of FIG. 51, a unique arrangement of three staples 3272″identifies the distal end 3275, while a unique arrangement of fourstaples 3272″ identifies the proximal end 3273. Identification of theproximal and distal ends of a staple deployment allows the imagingmodule 128 to distinguish between different staple deployments within acaptured frame, which can be useful in pointing the source of a leak,for example.

In various aspects, the imaging module 138 may detect a sealed tissue ina still frame of a remote surgical site captured by the frame grabber3200. Detection of the sealed tissue can be indicative of a surgicalstep that involves applying therapeutic energy to tissue.

Sealing tissue can be accomplished by the application of energy, such aselectrical energy, for example, to tissue captured or clamped within anend effector of a surgical instrument in order to cause thermal effectswithin the tissue. Various mono-polar and bi-polar RF surgicalinstruments and harmonic surgical instruments have been developed forsuch purposes. In general, the delivery of energy to captured tissue canelevate the temperature of the tissue and, as a result, the energy canat least partially denature proteins within the tissue. Such proteins,like collagen, for example, can be denatured into a proteinaceousamalgam that intermixes and fuses, or seals, together as the proteinsrenature.

Accordingly, sealed tissue has a distinct color and/or shape that can bedetected by the imaging module 138 using image recognition algorithms,for example. In addition, smoke detection at the surgical site canindicate that therapeutic energy application to the tissue is inprogress.

Further to the above, the imaging module 138 of the surgical hub 106 iscapable of differentiating between surgical steps of a surgicalprocedure based on the captured frames. As described above, a stillframe that comprises fired staples is indicative of a surgical stepinvolving tissue stapling, while a still frame that comprises a sealedtissue is indicative of a surgical step involving energy application totissue.

In one aspect, the surgical hub 106 may selectively overlay informationrelevant to a previously completed surgical task onto the livestream.For example, the overlaid information may comprise image data from astill frame of the surgical site captured during the previouslycompleted surgical task. Furthermore, guided by common landmarklocations at the surgical site, the imaging module 138 can interlace oneimage frame to another to establish and detect surgical locations andrelationship data of a previously completed surgical task.

In one example, the surgical hub 106 is configured to overlayinformation regarding a potential leak in a tissue treated by staplingor application of therapeutic energy in a previously completed surgicaltask. The potential leak can be spotted by the imaging module 138 duringthe processing of a still frame of the tissue. The surgical operator canbe alerted about the leak by overlaying information about the potentialleak onto the livestream.

In various aspects, still frames of an end effector of a surgicalinstrument at a surgical site can be used to identify the surgicalinstrument. For example, the end effector may include an identificationnumber that can be recognized by the imaging module 138 during imageprocessing of the still frame. Accordingly, the still frames captured bythe imaging module 138 may be used to identify a surgical instrumentutilized in a surgical step of a surgical procedure. The still framesmay also include useful information regarding the performance of thesurgical instrument. All such information can be uploaded to the cloud104 for data aggregation and further analysis.

In various examples, the surgical hub 106 may also selectively overlayinformation relevant to a current or upcoming surgical task, such as ananatomical location or a surgical instrument suitable for the surgicaltask.

The imaging module 138 may employ various images and edge detectiontechniques to track a surgical site where a surgical instrument was usedto complete a surgical task. Success or failure of the surgical task canthen be assessed. For example, a surgical instrument can be employed toseal and/or cut tissue at the surgical site. A still frame of thesurgical site can be stored in the memory 3202 or the storage array 134of the surgical hub 106, for example, upon completion of the surgicaltask.

In the following surgical step, the quality of the seal can be testedvia different mechanisms. To ensure that the testing is accuratelyapplied to the treated tissue, the stored still frame of the surgicalsite is overlaid onto the livestream in search of a match. Once a matchis found, the testing can take place. One or more additional stillframes can be taken during the testing, which can be later analyzed bythe imaging module 138 of the surgical hub 106. The testing mechanismsinclude bubble detection, bleeding detection, dye detection (where a dyeis employed at the surgical site), and/or burst stretch detection (wherea localized strain is applied adjacent to an anastomosis site), forexample.

The imaging module 138 may capture still frames of the response of thetreated tissue to these tests, which can be stored in the memory 3202 orthe storage array 134 of the surgical hub 106, for example. The stillframes can be stored alone or in combination with other data, such as,for example, data from the surgical instrument that performed the tissuetreatment. The paired data can also be uploaded to the cloud 104 foradditional analysis and/or pairing.

In various aspects, the still frames captured by the frame grabber 3200can be processed locally, paired with other data, and can also betransmitted to the cloud 104. The size of the processed and/ortransmitted data will depend on the number of captured frames. Invarious aspects, the rate at which the frame grabber 3200 captures thestill frames from the livestream can be varied in an effort to reducethe size of the data without sacrificing quality.

In one aspect, the frame-capturing rate may depend on the type ofsurgical task being performed. Certain surgical tasks may need a highernumber of still frames than others for an evaluation of success orfailure. The frame-capturing rate can be scalded to accommodate suchneeds.

In one aspect, the frame-capturing rate is dependent upon the detectedmotion of the imaging device 124. In use, an imaging device 124 maytarget one surgical site for a period of time. Observing no or minorchanges in the still frames captured while the imaging device 124 is notbeing moved, the imaging module 138 may reduce the frame-capturing rateof the frame grabber 3200. If the situation changes, however, wherefrequent motion is detected, the imaging module 138 may respond byincreasing the frame-capturing rate of the frame grabber 3200. In otherwords, the imaging module 138 may be configured to correlate theframe-capturing rate of the frame grabber 3200 with the detected degreeof motion of the imaging device 124.

For additional efficiency, only portions of the still frames, wheremotion is detected, need to be stored, processed, and/or transmitted tothe cloud 104. The imaging module 138 can be configured to select theportions of the still frames where motion is detected. In one example,motion detection can be achieved by comparing a still frame to apreviously captured still frame. If movement is detected, the imagingmodule 138 may cause the frame grabber 3200 to increase theframe-capturing rate, but only the portions where motion is detected arestored, processed, and/or transmitted to the cloud 104.

In another aspect, the data size can be managed by scaling theresolution of the captured information based on the area of the screenwhere the focal point is or where end effectors are located, forexample. The remainder of the screen could be captured at a lowerresolution.

In one aspect, the corners of the screen and the edges could generallybe captured at a lower resolution. The resolution, however, can bescalded up if an event of significance is observed.

During a surgical procedure, the surgical hub 106 can be connected tovarious operating-room monitoring devices, such as, for example, heartrate monitors and insufflation pumps. Data collected from these devicescan improve the situational awareness of the surgical hub 106. The hubsituational awareness is described in greater detail below in connectionwith FIG. 62.

In one example, the surgical hub 106 can be configured to utilizepatient data received from a heart rate monitor connected along withdata regarding the location of the surgical site to assess proximity ofthe surgical site to sensory nerves. An increase in the patient's heartrate, when combined with anatomical data indicating that the surgicalsite is in a region high in sensory nerves, can be construed as anindication of sensory nerve proximity. Anatomical data can be availableto the surgical hub 106 through accessing patient records (e.g., an EMRdatabase containing patient records).

The surgical hub 106 may be configured to determine the type of surgicalprocedure being performed on a patient from data received from one ormore of the operating-room monitoring devices, such as, for example,heart rate monitors and insufflation pumps. Abdominal surgicalprocedures generally require insufflation of the abdomen, whileinsufflation is not required in theoretic surgery. The surgical hub 106can be configured to determine whether a surgical procedure is anabdominal or a thoracic surgical procedure by detecting whether theinsufflation pump is active. In one aspect, the surgical hub 106 may beconfigured to monitor insufflation pressure on the output side of theinsufflation pump in order to determine whether the surgical procedurebeing performed is one that requires insufflation.

The surgical hub 106 may also gather information from other secondarydevices in the operating room to assess, for example, whether thesurgical procedure is a vascular or avascular procedure.

The surgical hub 106 may also monitor AC current supply to one or moreof its components to assess whether a component is active. In oneexample, the surgical hub 106 is configured to monitor AC current supplyto the generator module to assess whether the generator is active, whichcan be an indication that the surgical procedure being performed is onethat requires application of energy to seal tissue.

In various aspects, secondary devices in the operating room that areincapable of communication with the surgical hub 106 can be equippedwith communication interface devices (communication modules) that canfacilitate pairing of these devices with the surgical hub 106. In oneaspect, the communication interface devices may be configured to bebridging elements, which would allow them two-way communication betweenthe surgical hub 106 and such devices.

In one aspect, the surgical hub 106 can be configured to control one ormore operational parameters of a secondary device through acommunication interface device. For example, the surgical hub 106 can beconfigured to increase or decrease the insufflation pressure through acommunication interface device coupled to an insufflation device.

In one aspect, the communication interface device can be configured toengage with an interface port of the device. In another aspect, thecommunication interface device may comprise an overlay or otherinterface that directly interacts with a control panel of the secondarydevice. In other aspects, the secondary devices, such as, for example,the heart rate monitor and/or the insufflation devices, can be equippedwith integrated communication modules that allow them to pair with thehub for two-way communication therewith.

In one aspect, the surgical hub 106 can also be connected through acommunication interface device, for example, to muscle pads that areconnected to the neuro-stim detection devices to improve resolution of anerve-sensing device.

Furthermore, the surgical hub 106 can also be configured to manageoperating room supplies. Different surgical procedures require differentsupplies. For example, two different surgical procedures may requiredifferent sets of surgical instruments. Certain surgical procedures mayinvolve using a robotic system, while others may not. Furthermore, twodifferent surgical procedures may require staple cartridges that aredifferent in number, type, and/or size. Accordingly, the suppliesbrought into the operating room can provide clues as to the nature ofthe surgical procedure that will be performed.

In various aspects, the surgical hub 106 can be integrated with anoperating room supplies scanner to identify items pulled into theoperating room and introduced into the sterile field. The surgical hub106 may utilize data from the operating room supplies scanner, alongwith data from the devices of the surgical system 102 that are pairedwith the surgical hub 106, to autonomously determine the type ofsurgical procedure that will be performed. In one example, the surgicalhub 106 may record a list of serial numbers of the smart cartridge thatare going to be used in the surgical procedure. During the surgicalprocedure, the surgical hub 106 may gradually remove the staples thathave been fired, based on information collected from the staplecartridge chips. In one aspect, the surgical hub 106 is configured tomake sure that all the items are accounted for at the end of theprocedure.

Surgical Hub Control Arrangements

In a surgical procedure, a second surgical hub may be brought into anoperating room already under the control of a first surgical hub. Thesecond surgical hub can be, for example, a surgical robotic hub broughtinto the operating room as a part of a robotic system. Withoutcoordination between the first and second surgical hubs, the roboticsurgical hub will attempt to pair with all the other components of thesurgical system 102 that are within the operating room. The confusionarising from the competition between two hubs in a single operating roomcan lead to undesirable consequences. Also, sorting out the instrumentdistribution between the hubs during the surgical procedure can be timeconsuming.

Aspects of the present disclosure are presented for a surgical hub foruse with a surgical system in a surgical procedure performed in anoperating room. A control circuit of the surgical hub is configured todetermine the bounds of the operating room and establish a controlarrangement with a detected surgical hub located within the bounds ofthe operating room.

In one aspect, the control arrangement is a peer-to-peer arrangement. Inanother aspect, the control arrangement is a master-slave arrangement.In one aspect, the control circuit is configured to select one of amaster mode of operation or a slave mode of operation in themaster-slave arrangement. In one aspect, the control circuit isconfigured to surrender control of at least one surgical instrument tothe detected surgical hub in the slave mode of operation.

In one aspect, the surgical hub includes an operating room mappingcircuit that includes a plurality of non-contact sensors configured tomeasure the bounds of the operating room.

In various aspects, the surgical hub includes a processor and a memorycoupled to the processor. The memory stores instructions executable bythe processor to coordinate a control arrangement between surgical hubs,as described above. In various aspects, the present disclosure providesa non-transitory computer-readable medium storing computer-readableinstructions which, when executed, cause a machine to coordinate acontrol arrangement between surgical hubs, as described above.

Aspects of the present disclosure are presented for a surgical systemcomprising two independent surgical hubs that are configured to interactwith one another. Each of the hubs has their own linked surgical devicesand the control designation of and distribution of where data isrecorded and processed. This interaction causes one or both hubs tochange how they were behaving before the interaction. In one aspect, thechange involves a redistribution of devices previously assigned to eachof the hubs. In another aspect, the change involves establishing amaster-slave arrangement between the hubs. In yet another aspect, thechange can be a change in the location of the processing shared betweenthe hubs.

FIG. 53 is a logic flow diagram of a process depicting a control programor a logic configuration for coordinating a control arrangement betweensurgical hubs. The process of FIG. 53 is similar in many respects to theprocess of FIG. 35 except that the process of FIG. 53 addressesdetection of a surgical hub by another surgical hub. As illustrated inFIG. 53, the surgical hub 106 determines 3007 the bounds of theoperating room. After the initial determination, the surgical hub 106continuously searches for or detects 3008 devices within a pairingrange. If a device is detected 3010, and if the detected device islocated 3011 within the bounds of the operating room, the surgical hub106 pairs 3012 with the device and assigns 3013 an identifier to thedevice. If through an initial interaction, as described below in greaterdetail, the surgical hub 106 determines 3039 that the device is anothersurgical hub, a control arrangement is established 3040 therebetween.

Referring to FIG. 54, a robotic surgical hub 3300 enters an operatingroom already occupied by a surgical hub 3300. The robotic surgical hub3310 and the surgical hub 3300 are similar in many respects to othersurgical hubs described in greater detail elsewhere herein, such as, forexample, the surgical hubs 106. For example, the robotic surgical hub3310 includes non-contact sensors configured to measure the bounds ofthe operating room, as described in greater detail elsewhere herein inconnection with FIGS. 33, 34.

As the robotic surgical hub 3310 is powered up, it determines the boundsof the operating room and begins to pair with other components of thesurgical system 102 that are located within the bounds of the operatingroom. The robotic surgical hub 3310 pairs with a robotic advanced energytool 3311, a robotic stapler 3312, a monopolar energy tool 3313, and arobotic visualization tower 3314, which are all located within thebounds of the operating room. The surgical hub 3300 is already pairedwith a handheld stapler 3301, a handheld powered dissector 3302, asecondary display 3303, a surgeon interface 3304, and a visualizationtower 3305. Since the handheld stapler 3301, the handheld powereddissector 3302, the secondary display 3303, the surgeon interface 3304,and the visualization tower 3305 are already paired with the surgicalhub 3300, such devices cannot pair with another surgical hub withoutpermission from the surgical hub 3300.

Further to the above, the robotic surgical hub 3310 detects and/or isdetected by the surgical hub 3300. A communication link is establishedbetween the communication modules of the surgical hubs 3300, 3310. Thesurgical hubs 3300, 3310 then determine the nature of their interactionby determining a control arrangement therebetween. In one aspect, thecontrol arrangement can be a master-slave arrangement. In anotheraspect, the control arrangement can be a peer-to-peer arrangement.

In the example of FIG. 54, a master-slave arrangement is established.The surgical hubs 3300, 3310 request permission from a surgical operatorfor the robotic surgical hub 3310 to take control of the operating roomfrom the surgical hub 3300. The permission can be requested through asurgeon interface or console 3304. Once permission is granted, therobotic surgical hub 3310 requests the surgical hub 3300 to transfercontrol to the robotic surgical hub 3310.

Alternatively, the surgical hubs 3300, 3310 can negotiate the nature oftheir interaction without external input based on previously gathereddata. For example, the surgical hubs 3300, 3310 may collectivelydetermine that the next surgical task requires use of a robotic system.Such determination may cause the surgical hub 3300 to autonomouslysurrender control of the operating room to the robotic surgical hub3310. Upon completion of the surgical task, the robotic surgical hub3310 may then autonomously return the control of the operating room tosurgical hub 3300.

The outcome of the interaction between the surgical hubs 3300, 3310 isillustrated on the right of FIG. 54. The surgical hub 3300 hastransferred control to the robotic surgical hub 3310, which has alsotaken control of the surgeon interface 3304 and the secondary display3303 from the surgical hub 3300. The robotic surgical hub 3310 assignsnew identification numbers to the newly transferred devices. Thesurgical hub 3300 retains control the handheld stapler 3301, thehandheld powered dissector 3302, and visualization tower 3305. Inaddition, the surgical hub 3300 performs a supporting role, wherein theprocessing and storage capabilities of the surgical hub 3300 are nowavailable to the robotic surgical hub 3310.

FIG. 55 is a logic flow diagram of a process depicting a control programor a logic configuration for coordinating a control arrangement betweensurgical hubs. In various aspects, two independent surgical hubs willinteract with one another in a predetermined manner to assess the natureof their relationship. In one example, after establishing 3321 acommunication link, the surgical hubs exchange 3322 data packets. A datapacket may include type, identification number, and/or status of asurgical hub. A data packet may further include a record of devicesunder control of the surgical hub and/or any limited communicationconnections, such as data ports for other secondary operating roomdevices.

The control arrangement between the surgical hubs is then determined3323 based on input from a surgical operator or autonomously between thesurgical hubs. The surgical hubs may store instructions as to how todetermine a control arrangement therebetween. The control arrangementbetween two surgical hubs may depend on the type of surgical procedurebeing performed. The control arrangement between two surgical hubs maydepend on their types, identification information, and/or status. Thecontrol arrangement between two surgical hubs may depend on the devicespaired with the surgical hubs. The surgical hubs then redistribute 3324the devices of the surgical system 102 therebetween based upon thedetermined control arrangement.

In the master-slave arrangement, the record communication can beunidirectional from the slave hub to the master hub. The master hub mayalso require the slave hub to hand-off some of its wireless devices toconsolidate communication pathways. In one aspect, the slave hub can berelegated to a relay configuration with the master hub originating allcommands and recording all data. The slave hub can remain linked to themaster hub for a distributed sub-processing of the master hub commands,records, and/or controls. Such interaction expands the processingcapacity of the dual linked hubs beyond the capabilities of the masterhub by itself.

In a peer-to-peer arrangement, each surgical hub may retain control ofits devices. In one aspect, the surgical hubs may cooperate incontrolling a surgical instrument. In one aspect, an operator of thesurgical instrument may designate the surgical hub that will control thesurgical instrument at the time of its use.

Referring generally to FIGS. 56-61, the interaction between surgicalhubs can be extended beyond the bounds of the operating room. In variousaspects, surgical hubs in separate operating rooms may interact with oneanother within predefined limits. Depending on their relative proximity,surgical hubs in separate operating rooms may interact through anysuitable wired or wireless data communication network such as Bluetoothand WiFi. As used here, a “data communication network” represents anynumber of physical, virtual, or logical components, including hardware,software, firmware, and/or processing logic configured to support datacommunication between an originating component and a destinationcomponent, where data communication is carried out in accordance withone or more designated communication protocols over one or moredesignated communication media.

In various aspects, a first surgical operator in a first operating roommay wish to consult a second surgical operator in a second operatingroom, such as in case of an emergency. A temporary communication linkmay be established between the surgical hubs of the first and secondoperating room to facilitate the consult while the first and secondsurgical operators remain in their respective operating rooms.

The surgical operator being consulted can be presented with a consultrequest through the surgical hub in his/her operating room. If thesurgical operator accepts, he/she will have access to all the datacompiled by the surgical hub requesting the consult. The surgicaloperator may access all previously stored data, including a full historyof the procedure. In addition, a livestream of the surgical site at therequesting operating room can be transmitted through the surgical hubsto a display at the receiving operating room.

When a consult request begins, the receiving surgical hub begins torecord all received information in a temporarily storage location, whichcan be a dedicated portion of the storage array of the surgical hub. Atthe end of the consult, the temporary storage location is purged fromall the information. In one aspect, during a consult, the surgical hubrecords all accessible data, including blood pressure, ventilation data,oxygen stats, generator settings and uses, and all patient electronicdata. The recorded data will likely be more than the data stored by thesurgical hub during normal operation, which is helpful in providing thesurgical operator being consulted with as much information as possiblefor the consult.

Referring to FIG. 56, a non-limiting example of an interaction betweensurgical hubs in different operating rooms is depicted. FIG. 56 depictsan operating room OR 1 that includes a surgical system 3400 supporting athoracic segmentectomy and a second operating room OR 3 that includes asurgical system 3410 supporting a colorectal procedure. The surgicalsystem 3400 includes surgical hub 3401, surgical hub 3402, and roboticsurgical hub 3403. The surgical system 3400 further includes a personalinterface 3406, a primary display 3408, and secondary displays 3404,3405. The surgical system 3410 includes a surgical hub 3411 and asecondary display 3412. For clarity, several components of the surgicalsystems 3400, 3410 are removed.

In the example of FIG. 56, the surgical operator of OR 3 is requesting aconsult from the surgical operator of OR 1. A surgical hub 3411 of theOR 3 transmits the consult request to one of the surgical hubs of the OR1, such as the surgical hub 3401. In OR 1, the surgical hub 3401presents the request at a personal interface 3406 held by the surgicaloperator. The consult is regarding selecting an optimal location of acolon transection. The surgical operator of OR 1, through a personalinterface 3406, recommends an optimal location for the transection sitethat avoids a highly vascular section of the colon. The recommendationis transmitted in real time through the surgical hubs 3401, 3411.Accordingly, the surgical operator is able to respond to the consultrequest in real time without having to leave the sterile field of hisown operating room. The surgical operator requesting the consult alsodid not have to leave the sterile field of OR 3.

If the surgical hub 3401 is not in communication with the personalinterface 3406, it may relay the message to another surgical hub suchas, for example, the surgical hub 3402 or the robotic surgical hub 3403.Alternatively, the surgical hub 3401 may request control of the personalinterface 3406 from another surgical hub.

In any event, if the surgical operator of OR 1 decides to accept theconsult request, a livestream, or frames, of a surgical site 3413 of thecolorectal procedure of OR 3 is transmitted to OR 1 through a connectionestablished between the surgical hubs 3401, 3411, for example. FIG. 57illustrates a livestream of the surgical site 3413 displayed on asecondary display of OR 3. The surgical hubs 3401, 3411 cooperate totransmit the livestream of the surgical site of OR 3 to the personalinterface 3406 of the OR 1, as illustrated in FIG. 58.

Referring to FIGS. 59-61, the surgical operator may expand thelaparoscopic livestream from OR 3 onto the primary display 3405 in OR 1,for example, through the controls of the personal interface 3406. Thepersonal interface 3406 allows the surgical operator to select adestination for the livestream by presenting the surgical operator withicons that represent the displays that are available in OR 1, asillustrated in FIG. 60. Other navigation controls 3407 are available tothe surgical operator through the personal interface 3406, asillustrated in FIG. 61. For example, the personal interface 3406includes navigation controls for adjusting the livestream of thesurgical site of OR 3 in OR 1 by the surgical operator moving his or herfingers on the livestream displayed on the personal interface 3406. Tovisualize the high vasculature regions, the consulted surgical operatormay change the view of the livestream from OR 3 through the personalinterface 3406 to an advanced imaging screen. The surgical operator maythen manipulate the image in multiple planes to see the vascularizationusing a wide-angle multi-spectral view, for example.

As illustrated in FIG. 61, the surgical operator also has access to anarray of relevant information 3420, such as, for example, heart rate,blood pressure, ventilation data, oxygen stats, generator settings anduses, and all patient electronic data of the patient in OR 3.

Situational Awareness

Situational awareness is the ability of some aspects of a surgicalsystem to determine or infer information related to a surgical procedurefrom data received from databases and/or instruments. The informationcan include the type of procedure being undertaken, the type of tissuebeing operated on, or the body cavity that is the subject of theprocedure. With the contextual information related to the surgicalprocedure, the surgical system can, for example, improve the manner inwhich it controls the modular devices (e.g., a robotic arm and/orrobotic surgical tool) that are connected to it and providecontextualized information or suggestions to the surgeon during thecourse of the surgical procedure.

Referring now to FIG. 62, a timeline 5200 depicting situationalawareness of a hub, such as the surgical hub 106 or 206, for example, isdepicted. The timeline 5200 is an illustrative surgical procedure andthe contextual information that the surgical hub 106, 206 can derivefrom the data received from the data sources at each step in thesurgical procedure. The timeline 5200 depicts the typical steps thatwould be taken by the nurses, surgeons, and other medical personnelduring the course of a lung segmentectomy procedure, beginning withsetting up the operating theater and ending with transferring thepatient to a post-operative recovery room.

The situationally aware surgical hub 106, 206 receives data from thedata sources throughout the course of the surgical procedure, includingdata generated each time medical personnel utilize a modular device thatis paired with the surgical hub 106, 206. The surgical hub 106, 206 canreceive this data from the paired modular devices and other data sourcesand continually derive inferences (i.e., contextual information) aboutthe ongoing procedure as new data is received, such as which step of theprocedure is being performed at any given time. The situationalawareness system of the surgical hub 106, 206 is able to, for example,record data pertaining to the procedure for generating reports, verifythe steps being taken by the medical personnel, provide data or prompts(e.g., via a display screen) that may be pertinent for the particularprocedural step, adjust modular devices based on the context (e.g.,activate monitors, adjust the field of view of the medical imagingdevice, or change the energy level of an ultrasonic surgical instrumentor RF electrosurgical instrument), and take any other such actiondescribed above.

As the first step 5202 in this illustrative procedure, the hospitalstaff members retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 106,206 determines that the procedure to be performed is a thoracicprocedure.

In the second step 5204, the staff members scan the incoming medicalsupplies for the procedure. The surgical hub 106, 206 cross-referencesthe scanned supplies with a list of supplies that are utilized invarious types of procedures and confirms that the mix of suppliescorresponds to a thoracic procedure. Further, the surgical hub 106, 206is also able to determine that the procedure is not a wedge procedure(because the incoming supplies either lack certain supplies that arenecessary for a thoracic wedge procedure or do not otherwise correspondto a thoracic wedge procedure).

In the third step 5206, the medical personnel scan the patient band viaa scanner that is communicably connected to the surgical hub 106, 206.The surgical hub 106, 206 can then confirm the patient's identity basedon the scanned data.

In the fourth step 5208, the medical staff turns on the auxiliaryequipment. The auxiliary equipment being utilized can vary according tothe type of surgical procedure and the techniques to be used by thesurgeon, but in this illustrative case, they include a smoke evacuator,insufflator, and medical imaging device. When activated, the auxiliaryequipment that are modular devices can automatically pair with thesurgical hub 106, 206 that is located within a particular vicinity ofthe modular devices as part of their initialization process. Thesurgical hub 106, 206 can then derive contextual information about thesurgical procedure by detecting the types of modular devices that pairwith it during this pre-operative or initialization phase. In thisparticular example, the surgical hub 106, 206 determines that thesurgical procedure is a VATS procedure based on this particularcombination of paired modular devices. Based on the combination of thedata from the patient's EMR, the list of medical supplies to be used inthe procedure, and the type of modular devices that connect to the hub,the surgical hub 106, 206 can generally infer the specific procedurethat the surgical team will be performing. Once the surgical hub 106,206 knows what specific procedure is being performed, the surgical hub106, 206 can then retrieve the steps of that procedure from a memory orfrom the cloud and then cross-reference the data it subsequentlyreceives from the connected data sources (e.g., modular devices andpatient monitoring devices) to infer what step of the surgical procedurethe surgical team is performing.

In the fifth step 5210, the staff members attach the EKG electrodes andother patient monitoring devices to the patient. The EKG electrodes andother patient monitoring devices are able to pair with the surgical hub106, 206. As the surgical hub 106, 206 begins receiving data from thepatient monitoring devices, the surgical hub 106, 206 thus confirms thatthe patient is in the operating theater.

In the sixth step 5212, the medical personnel induce anesthesia in thepatient. The surgical hub 106, 206 can infer that the patient is underanesthesia based on data from the modular devices and/or patientmonitoring devices, including EKG data, blood pressure data, ventilatordata, or combinations thereof, for example. Upon completion of the sixthstep 5212, the pre-operative portion of the lung segmentectomy procedureis completed and the operative portion begins.

In the seventh step 5214, the patient's lung that is being operated onis collapsed (while ventilation is switched to the contralateral lung).The surgical hub 106, 206 can infer from the ventilator data that thepatient's lung has been collapsed, for example. The surgical hub 106,206 can infer that the operative portion of the procedure has commenced,as it can compare the detection of the patient's lung collapsing to theexpected steps of the procedure (which can be accessed or retrievedpreviously) and thereby determine that collapsing the lung is the firstoperative step in this particular procedure.

In the eighth step 5216, the medical imaging device (e.g., a scope) isinserted and video from the medical imaging device is initiated. Thesurgical hub 106, 206 receives the medical imaging device data (i.e.,video or image data) through its connection to the medical imagingdevice. Upon receipt of the medical imaging device data, the surgicalhub 106, 206 can determine that the laparoscopic portion of the surgicalprocedure has commenced. Further, the surgical hub 106, 206 candetermine that the particular procedure being performed is asegmentectomy, as opposed to a lobectomy (note that a wedge procedurehas already been discounted by the surgical hub 106, 206 based on datareceived at the second step 5204 of the procedure). The data from themedical imaging device 124 (FIG. 2) can be utilized to determinecontextual information regarding the type of procedure being performedin a number of different ways, including by determining the angle atwhich the medical imaging device is oriented with respect to thevisualization of the patient's anatomy, monitoring the number of medicalimaging devices being utilized (i.e., that are activated and paired withthe surgical hub 106, 206), and monitoring the types of visualizationdevices utilized. For example, one technique for performing a VATSlobectomy places the camera in the lower anterior corner of thepatient's chest cavity above the diaphragm, whereas one technique forperforming a VATS segmentectomy places the camera in an anteriorintercostal position relative to the segmental fissure. Using patternrecognition or machine learning techniques, for example, the situationalawareness system can be trained to recognize the positioning of themedical imaging device according to the visualization of the patient'sanatomy. As another example, one technique for performing a VATSlobectomy utilizes a single medical imaging device, whereas anothertechnique for performing a VATS segmentectomy utilizes multiple cameras.As yet another example, one technique for performing a VATSsegmentectomy utilizes an infrared light source (which can becommunicably coupled to the surgical hub as part of the visualizationsystem) to visualize the segmental fissure, which is not utilized in aVATS lobectomy. By tracking any or all of this data from the medicalimaging device, the surgical hub 106, 206 can thereby determine thespecific type of surgical procedure being performed and/or the techniquebeing used for a particular type of surgical procedure.

In the ninth step 5218, the surgical team begins the dissection step ofthe procedure. The surgical hub 106, 206 can infer that the surgeon isin the process of dissecting to mobilize the patient's lung because itreceives data from the RF or ultrasonic generator indicating that anenergy instrument is being fired. The surgical hub 106, 206 cancross-reference the received data with the retrieved steps of thesurgical procedure to determine that an energy instrument being fired atthis point in the process (i.e., after the completion of the previouslydiscussed steps of the procedure) corresponds to the dissection step. Incertain instances, the energy instrument can be an energy tool mountedto a robotic arm of a robotic surgical system.

In the tenth step 5220, the surgical team proceeds to the ligation stepof the procedure. The surgical hub 106, 206 can infer that the surgeonis ligating arteries and veins because it receives data from thesurgical stapling and cutting instrument indicating that the instrumentis being fired. Similarly to the prior step, the surgical hub 106, 206can derive this inference by cross-referencing the receipt of data fromthe surgical stapling and cutting instrument with the retrieved steps inthe process. In certain instances, the surgical instrument can be asurgical tool mounted to a robotic arm of a robotic surgical system.

In the eleventh step 5222, the segmentectomy portion of the procedure isperformed. The surgical hub 106, 206 can infer that the surgeon istransecting the parenchyma based on data from the surgical stapling andcutting instrument, including data from its cartridge. The cartridgedata can correspond to the size or type of staple being fired by theinstrument, for example. As different types of staples are utilized fordifferent types of tissues, the cartridge data can thus indicate thetype of tissue being stapled and/or transected. In this case, the typeof staple being fired is utilized for parenchyma (or other similartissue types), which allows the surgical hub 106, 206 to infer that thesegmentectomy portion of the procedure is being performed.

In the twelfth step 5224, the node dissection step is then performed.The surgical hub 106, 206 can infer that the surgical team is dissectingthe node and performing a leak test based on data received from thegenerator indicating that an RF or ultrasonic instrument is being fired.For this particular procedure, an RF or ultrasonic instrument beingutilized after parenchyma was transected corresponds to the nodedissection step, which allows the surgical hub 106, 206 to make thisinference. It should be noted that surgeons regularly switch back andforth between surgical stapling/cutting instruments and surgical energy(i.e., RF or ultrasonic) instruments depending upon the particular stepin the procedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/cutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing.Moreover, in certain instances, robotic tools can be utilized for one ormore steps in a surgical procedure and/or handheld surgical instrumentscan be utilized for one or more steps in a surgical procedure. Thesurgeon(s) can alternate between robotic tools and handheld surgicalinstruments and/or can use the devices concurrently, for example. Uponcompletion of the twelfth step 5224, the incisions are closed up and thepost-operative portion of the procedure begins.

In the thirteenth step 5226, the patient's anesthesia is reversed. Thesurgical hub 106, 206 can infer that the patient is emerging from theanesthesia based on the ventilator data (i.e., the patient's breathingrate begins increasing), for example.

Lastly, in the fourteenth step 5228, the medical personnel remove thevarious patient monitoring devices from the patient. The surgical hub106, 206 can thus infer that the patient is being transferred to arecovery room when the hub loses EKG, BP, and other data from thepatient monitoring devices. As can be seen from the description of thisillustrative procedure, the surgical hub 106, 206 can determine or inferwhen each step of a given surgical procedure is taking place accordingto data received from the various data sources that are communicablycoupled to the surgical hub 106, 206.

Situational awareness is further described in U.S. Provisional PatentApplication Ser. No. 62/611,341, entitled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is incorporated by reference herein in itsentirety. In certain instances, operation of a robotic surgical system,including the various robotic surgical systems disclosed herein, forexample, can be controlled by the surgical hub 106, 206 based on itssituational awareness and/or feedback from the components thereof and/orbased on information from the cloud 102.

Various aspects of the subject matter described herein are set out inthe following numbered examples.

Example 1

A surgical hub configured to authenticate data communications withsurgical devices, the surgical hub comprising: a processor; and a memorycoupled to the processor, the memory storing instructions executable bythe processor to: detect that a surgical device is communicativelycoupled to the surgical hub; transmit a public key associated with thesurgical hub to the surgical device; receive a message from the surgicaldevice, wherein the message is encrypted using the public key associatedwith the surgical hub, wherein the encrypted message comprises a sharedsecret associated with the surgical device and a checksum functionassociated with the shared secret, and wherein the shared secretcomprises an identifier assigned to the surgical device; decrypt theencrypted message, using a private key associated with the transmittedpublic key, to reveal the shared secret and the checksum function;receive data communications from the surgical device, wherein each datacommunication is encrypted using the shared secret received from thesurgical device, and wherein each data communication comprises achecksum value, derived via the checksum function, based on the data ofeach received communication; and decrypt each data communication usingthe shared secret until the surgical device is decoupled from thesurgical hub, wherein the integrity of each data communication isverifiable based on its associated checksum value.

Example 2

The surgical hub of Example 1, wherein the identifier assigned to thesurgical device comprises a unique serial number of the surgical device.

Example 3

The surgical hub of any one of Examples 1-2, wherein the instructionsare further executable by the processor to: transmit a message to acloud-based system communicatively coupled to a plurality of surgicalhubs, wherein the message is encrypted using the public key associatedwith the cloud-based system, wherein the encrypted message comprises theshared secret associated with the surgical device, and wherein theshared secret comprises the identifier assigned to the surgical device;and transmit each data communication received from the surgical deviceto the cloud-based system, wherein each data communication is encryptedusing the shared secret received from the surgical device to allow thecloud-based system to decrypt each data communication using the sharedsecret until the surgical device is decoupled from the surgical hub.

Example 4

The surgical hub of any one of Examples 1-3, wherein the instructionsare further executable by the processor to: detect that amulti-component surgical device comprising a plurality of sub-componentsis communicatively coupled to the surgical hub, wherein eachsub-component is associated with an identifier; transmit a public keyassociated with the surgical hub to the multi-component surgical device;receive a message from the multi-component surgical device, wherein themessage is encrypted using the public key associated with the surgicalhub, wherein the encrypted message comprises a shared secret associatedwith the multi-component surgical device and a checksum functionassociated with the shared secret, and wherein the shared secretcomprises a unique string of the identifiers associated with theplurality of sub-components that combine to form the multi-componentsurgical device; decrypt the encrypted message, using a private keyassociated with the transmitted public key, to reveal the shared secretand the checksum function; receive data communications from themulti-component surgical device, wherein each data communication isencrypted using the shared secret received from the multi-componentsurgical device, and wherein each data communication comprises achecksum value, derived via the checksum function, based on the data ofeach received communication; and decrypt each data communication usingthe shared secret until the multi-component surgical device is decoupledfrom the surgical hub, wherein the integrity of each data communicationis verifiable based on its associated checksum value.

Example 5

The surgical hub of Example 4, wherein the unique string of theidentifiers associated with the plurality of sub-components that combineto form the multi-component surgical device comprises a random orderingof the identifiers associated with the plurality of sub-components.

Example 6

The surgical hub of Example 5, wherein each identifier of the uniquestring of identifiers comprises a unique serial number associated witheach respective sub-component of the multi-component surgical device.

Example 7

A surgical hub configured to authenticate data communications withsurgical devices, the surgical hub comprising a control circuitconfigured to: detect that a surgical device is communicatively coupledto the surgical hub; transmit a public key associated with the surgicalhub to the surgical device; receive a message from the surgical device,wherein the message is encrypted using the public key associated withthe surgical hub, wherein the encrypted message comprises a sharedsecret associated with the surgical device and a checksum functionassociated with the shared secret, and wherein the shared secretcomprises an identifier assigned to the surgical device; decrypt theencrypted message, using a private key associated with the transmittedpublic key, to reveal the shared secret and the checksum function;receive data communications from the surgical device, wherein each datacommunication is encrypted using the shared secret received from thesurgical device, and wherein each data communication comprises achecksum value, derived via the checksum function, based on the data ofeach received communication; and decrypt each data communication usingthe shared secret until the surgical device is decoupled from thesurgical hub, wherein the integrity of each data communication isverifiable based on its associated checksum value.

Example 8

A surgical hub configured to authenticate surgical devices coupled tothe surgical hub, the surgical hub comprising: a processor; and a memorycoupled to the processor, the memory storing instructions executable bythe processor to: detect that a surgical device is communicativelycoupled to the surgical hub; receive an encrypted identifier and asource ID from the surgical device; transmit a first message from thesurgical hub to a server of a surgical device manufacturer associatedwith the source ID, wherein the first message comprises the encryptedidentifier, and wherein the first message is encrypted using a publickey associated with the surgical device manufacturer; receive a secondmessage from the server of the surgical device manufacturer, wherein thesecond message is encrypted using a public key associated with thesurgical hub, and wherein the encrypted second message comprises ashared secret associated with the encrypted identifier of the surgicaldevice; decrypt the encrypted second message using a private keyassociated with the public key used to encrypt the second message toreveal the shared secret associated with the encrypted identifier of thesurgical device; and decrypt the encrypted identifier of the surgicaldevice using the shared secret to reveal the identifier to authenticatethe surgical device and its manufacturer.

Example 9

The surgical hub of any one of Example 8, wherein the identifiercomprises a unique serial number of the surgical device.

Example 10

The surgical hub of any one of Examples 8-9, wherein the instructionsare further executable by the processor to: compare the decryptedidentifier to a list of authorized identifiers; and permit use of thesurgical device based on a match of the decrypted identifier to anauthorized identifier in the list.

Example 11

The surgical hub of Example 10, wherein the instructions are furtherexecutable by the processor to: download the list of authorizedidentifiers from a cloud-based system communicatively coupled to aplurality of surgical hubs.

Example 12

The surgical hub of any one of Examples 8-11, wherein receiving theencrypted identifier and the source ID from the surgical devicecomprises: reading the encrypted identifier and the source ID from amemory device of the surgical device.

Example 13

The surgical hub of any one of Examples 8-12, wherein the instructionsare further executable by the processor to: read usage data from amemory device of the coupled surgical device; store at least a portionof the read usage data each time the surgical device is coupled to thesurgical hub; compare the read usage data to previously stored usagedata to identify a discrepancy in the usage data; and prevent usage ofthe surgical device with the surgical hub based on an identifieddiscrepancy.

Example 14

The surgical hub of any one of Examples 8-13, wherein the instructionsare further executable by the processor to: transmit a record of thecoupling of the surgical device and the surgical hub to at least one ofa cloud-based system or a plurality of other surgical hubscommunicatively coupled to the cloud-based system in a surgical system,wherein the record links the unique identifier assigned to the surgicaldevice to a unique identifier assigned to the surgical hub.

Example 15

The surgical hub of any one of Examples 8-14, wherein the uniqueidentifier assigned to the surgical device comprises a serial number.

Example 16

The surgical hub of any one of Examples 8-15, wherein the instructionsare further executable by the processor to: store the record of thecoupling of the surgical device and the surgical hub as a genesisrecord, wherein the genesis record comprises a timestamp.

Example 17

The surgical hub of any one of Examples 8-16, wherein the instructionsare further executable by the processor to: store a new record for eachsubsequent coupling of the surgical device to the surgical hub, whereineach new record in a chain of records associated with the surgicaldevice comprises a cryptographic hash of the most recent record, thelinkage of the unique identifier assigned to the surgical device to theunique identifier assigned to the surgical hub, and a timestamp.

Example 18

The surgical hub of any one of Examples 8-17, wherein the instructionsare further executable by the processor to: receive a record of acoupling of the surgical device to one of the plurality of othersurgical hubs communicatively coupled to the cloud-based system; andstore a new record for the coupling of the surgical device to the one ofthe plurality of other surgical hubs, wherein the new record in a chainof records associated with the surgical device comprises a cryptographichash of the most recent record, a linkage of the unique identifierassigned to the surgical device to a unique identifier assigned to theone of the plurality of other surgical hubs, and a timestamp.

Example 19

The surgical hub of Example 18, wherein the instructions are furtherexecutable by the processor to: trace couplings of the surgical deviceto the surgical hub and the plurality of other surgical hubs in thesurgical system back to the genesis record.

Example 20

The surgical hub of Example 19, wherein the instructions are furtherexecutable by the processor to: analyze the traced couplings todetermine whether past usage of the surgical device contributed to orcaused a failure event.

While several forms have been illustrated and described, it is not theintention of the applicant to restrict or limit the scope of theappended claims to such detail. Numerous modifications, variations,changes, substitutions, combinations, and equivalents to those forms maybe implemented and will occur to those skilled in the art withoutdeparting from the scope of the present disclosure. Moreover, thestructure of each element associated with the described forms can bealternatively described as a means for providing the function performedby the element. Also, where materials are disclosed for certaincomponents, other materials may be used. It is therefore to beunderstood that the foregoing description and the appended claims areintended to cover all such modifications, combinations, and variationsas falling within the scope of the disclosed forms. The appended claimsare intended to cover all such modifications, variations, changes,substitutions, modifications, and equivalents.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof.Those skilled in the art will recognize that some aspects of the formsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, those skilled inthe art will appreciate that the mechanisms of the subject matterdescribed herein are capable of being distributed as one or more programproducts in a variety of forms, and that an illustrative form of thesubject matter described herein applies regardless of the particulartype of signal bearing medium used to actually carry out thedistribution.

Instructions used to program logic to perform various disclosed aspectscan be stored within a memory in the system, such as dynamic randomaccess memory (DRAM), cache, flash memory, or other storage.Furthermore, the instructions can be distributed via a network or by wayof other computer readable media. Thus a machine-readable medium mayinclude any mechanism for storing or transmitting information in a formreadable by a machine (e.g., a computer), but is not limited to, floppydiskettes, optical disks, compact disc, read-only memory (CD-ROMs), andmagneto-optical disks, read-only memory (ROMs), random access memory(RAM), erasable programmable read-only memory (EPROM), electricallyerasable programmable read-only memory (EEPROM), magnetic or opticalcards, flash memory, or a tangible, machine-readable storage used in thetransmission of information over the Internet via electrical, optical,acoustical or other forms of propagated signals (e.g., carrier waves,infrared signals, digital signals, etc.). Accordingly, thenon-transitory computer-readable medium includes any type of tangiblemachine-readable medium suitable for storing or transmitting electronicinstructions or information in a form readable by a machine (e.g., acomputer).

As used in any aspect herein, the term “control circuit” may refer to,for example, hardwired circuitry, programmable circuitry (e.g., acomputer processor comprising one or more individual instructionprocessing cores, processing unit, processor, microcontroller,microcontroller unit, controller, digital signal processor (DSP),programmable logic device (PLD), programmable logic array (PLA), orfield programmable gate array (FPGA)), state machine circuitry, firmwarethat stores instructions executed by programmable circuitry, and anycombination thereof. The control circuit may, collectively orindividually, be embodied as circuitry that forms part of a largersystem, for example, an integrated circuit (IC), an application-specificintegrated circuit (ASIC), a system on-chip (SoC), desktop computers,laptop computers, tablet computers, servers, smart phones, etc.Accordingly, as used herein “control circuit” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of random access memory), and/or electricalcircuitry forming a communications device (e.g., a modem, communicationsswitch, or optical-electrical equipment). Those having skill in the artwill recognize that the subject matter described herein may beimplemented in an analog or digital fashion or some combination thereof.

As used in any aspect herein, the term “logic” may refer to an app,software, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices.

As used in any aspect herein, the terms “component,” “system,” “module”and the like can refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution.

As used in any aspect herein, an “algorithm” refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities and/or logic states which may,though need not necessarily, take the form of electrical or magneticsignals capable of being stored, transferred, combined, compared, andotherwise manipulated. It is common usage to refer to these signals asbits, values, elements, symbols, characters, terms, numbers, or thelike. These and similar terms may be associated with the appropriatephysical quantities and are merely convenient labels applied to thesequantities and/or states.

A network may include a packet switched network. The communicationdevices may be capable of communicating with each other using a selectedpacket switched network communications protocol. One examplecommunications protocol may include an Ethernet communications protocolwhich may be capable permitting communication using a TransmissionControl Protocol/Internet Protocol (TCP/IP). The Ethernet protocol maycomply or be compatible with the Ethernet standard published by theInstitute of Electrical and Electronics Engineers (IEEE) titled “IEEE802.3 Standard”, published in December, 2008 and/or later versions ofthis standard. Alternatively or additionally, the communication devicesmay be capable of communicating with each other using an X.25communications protocol. The X.25 communications protocol may comply orbe compatible with a standard promulgated by the InternationalTelecommunication Union-Telecommunication Standardization Sector(ITU-T). Alternatively or additionally, the communication devices may becapable of communicating with each other using a frame relaycommunications protocol. The frame relay communications protocol maycomply or be compatible with a standard promulgated by ConsultativeCommittee for International Telegraph and Telephone (CCITT) and/or theAmerican National Standards Institute (ANSI). Alternatively oradditionally, the transceivers may be capable of communicating with eachother using an Asynchronous Transfer Mode (ATM) communications protocol.The ATM communications protocol may comply or be compatible with an ATMstandard published by the ATM Forum titled “ATM-MPLS NetworkInterworking 2.0” published August 2001, and/or later versions of thisstandard. Of course, different and/or after-developedconnection-oriented network communication protocols are equallycontemplated herein.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing,” “computing,”“calculating,” “determining,” “displaying,” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

One or more components may be referred to herein as “configured to,”“configurable to,” “operable/operative to,” “adapted/adaptable,” “ableto,” “conformable/conformed to,” etc. Those skilled in the art willrecognize that “configured to” can generally encompass active-statecomponents and/or inactive-state components and/or standby-statecomponents, unless context requires otherwise.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” refers to the portion closest to the clinician andthe term “distal” refers to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical”, “horizontal”, “up”, and “down” may beused herein with respect to the drawings. However, surgical instrumentsare used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

Those skilled in the art will recognize that, in general, terms usedherein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flow diagrams arepresented in a sequence(s), it should be understood that the variousoperations may be performed in other orders than those which areillustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“an exemplification,” “one exemplification,” and the like means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in one aspect,” “in an aspect,” “in an exemplification,”and “in one exemplification” in various places throughout thespecification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or otherdisclosure material referred to in this specification and/or listed inany Application Data Sheet is incorporated by reference herein, to theextent that the incorporated materials is not inconsistent herewith. Assuch, and to the extent necessary, the disclosure as explicitly setforth herein supersedes any conflicting material incorporated herein byreference. Any material, or portion thereof, that is said to beincorporated by reference herein, but which conflicts with existingdefinitions, statements, or other disclosure material set forth hereinwill only be incorporated to the extent that no conflict arises betweenthat incorporated material and the existing disclosure material.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

What is claimed is:
 1. A surgical hub configured to authenticate datacommunications with surgical devices, the surgical hub comprising: aprocessor; and a memory coupled to the processor, the memory storinginstructions executable by the processor to: detect that a surgicaldevice is communicatively coupled to the surgical hub; transmit a publickey associated with the surgical huh to the surgical device; receive amessage from the surgical device, wherein the message is encrypted usingthe public key associated with the surgical hub, wherein the encryptedmessage comprises a shared secret associated with the surgical deviceand a checksum function associated with the shared secret, and whereinthe shared secret comprises an identifier assigned to the surgicaldevice; decrypt the encrypted message, using a private key associatedwith the transmitted public key, to reveal the shared secret and thechecksum function; receive data communications from the surgical device,wherein each data communication is encrypted using the shared secretreceived from the surgical device, and wherein each data communicationcomprises a checksum value, derived via the checksum function, based onthe data of each received data communication; decrypt each datacommunication using the shared secret until the surgical device isdecoupled from the surgical hub, wherein an integrity of each datacommunication is verifiable based on its associated checksum value; andtransmit each data communication received from the surgical device to acloud-based system, wherein each data communication is encrypted usingthe shared secret received from the surgical device to allow thecloud-based system to decrypt each data communication using the sharedsecret until the surgical device is decoupled from the surgical hub. 2.The surgical hub of claim 1, wherein the identifier assigned to thesurgical device comprises a unique serial number of the surgical device.3. The surgical hub of claim 1, wherein the instructions are furtherexecutable by the processor to: transmit a second message to acloud-based system communicatively coupled to a plurality of surgicalhubs, wherein the second message is encrypted using the public keyassociated with the cloud-based system, wherein the encrypted secondmessage comprises the shared secret associated with the surgical device,and wherein the shared secret comprises the identifier assigned to thesurgical device.
 4. The surgical hub of claim 1, wherein theinstructions are further executable by the processor to: detect that amulti-component surgical device comprising a plurality of sub-componentsis communicatively coupled to the surgical hub, wherein eachsub-component is associated with a second identifier; transmit a secondpublic key associated with the surgical hub to the multi-componentsurgical device; receive a second message from the multi-componentsurgical device, wherein the second message is encrypted using thesecond public key associated with the surgical hub, wherein theencrypted second message comprises a second shared secret associatedwith the multi-component surgical device and a second checksum functionassociated with the second shared secret, and wherein the second sharedsecret comprises a unique string of the second identifiers associatedwith the plurality of sub-components that combine to form themulti-component surgical device; decrypt the encrypted second message,using a second private key associated with the transmitted second publickey, to reveal the second shared secret and the second checksumfunction; receive second data communications from the multi-componentsurgical device, wherein each second data communication is encryptedusing the second shared secret received from the multi-componentsurgical device, and wherein each second data communication comprises asecond checksum value, derived via the second checksum function, basedon the data of each received second data communication; and decrypt eachsecond data communication using the second shared secret until themulti-component surgical device is decoupled from the surgical hub,wherein the integrity of each second data communication is verifiablebased on its associated second checksum value.
 5. The surgical hub ofclaim 4, wherein the unique string of the second identifiers associatedwith the plurality of sub-components that combine to form themulti-component surgical device comprises a random ordering of thesecond identifiers associated with the plurality of sub-components. 6.The surgical hub of claim 5, wherein each second identifier of theunique string of the second identifiers comprises a unique serial numberassociated with each respective sub-component of the multi-componentsurgical device.
 7. A surgical hub configured to authenticate datacommunications with surgical devices, the surgical hub comprising acontrol circuit configured to: detect that a surgical device iscommunicatively coupled to the surgical hub; transmit a public keyassociated with the surgical hub to the surgical device; receive amessage from the surgical device, wherein the message is encrypted usingthe public key associated with the surgical hub, wherein the encryptedmessage comprises a shared secret associated with the surgical deviceand a checksum function associated with the shared secret, and whereinthe shared secret comprises an identifier assigned to the surgicaldevice; decrypt the encrypted message, using a private key associatedwith the transmitted public key, to reveal the shared secret and thechecksum function; receive data communications from the surgical device,wherein each data communication is encrypted using the shared secretreceived from the surgical device, and wherein each data communicationcomprises a checksum value, derived via the checksum function, based onthe data of each received data communication; decrypt each datacommunication using the shared secret until the surgical device isdecoupled from the surgical hub, wherein an integrity of each datacommunication is verifiable based on its associated checksum value; andtransmit each data communication received from the surgical device tothe cloud-based system, wherein each data communication is encryptedusing the shared secret received from the surgical device to allow thecloud-based system to decrypt each data communication using the sharedsecret until the surgical device is decoupled from the surgical hub. 8.A surgical hub configured to authenticate surgical devices coupled tothe surgical hub, the surgical hub comprising: a processor; and a memorycoupled to the processor, the memory storing instructions executable bythe processor to: detect that a surgical device is communicativelycoupled to the surgical hub; receive an encrypted identifier and asource ID from the surgical device; transmit a first message from thesurgical hub to a server of a surgical device manufacturer associatedwith the source ID, wherein the first message comprises the encryptedidentifier, and wherein the first message is encrypted using a publickey associated with the surgical device manufacturer; receive a secondmessage from the server of the surgical device manufacturer, wherein thesecond message is encrypted using a second public key associated withthe surgical hub, and wherein the encrypted second message comprises ashared secret associated with the encrypted identifier of the surgicaldevice; decrypt the encrypted second message using a private keyassociated with the second public key used to encrypt the second messageto reveal the shared secret associated with the encrypted identifier ofthe surgical device; decrypt the encrypted identifier of the surgicaldevice using the shared secret to reveal a unique identifier toauthenticate the surgical device and its manufacturer; and transmit arecord of the coupling of the surgical device and the surgical hub to atleast one of a cloud-based system or a plurality of other surgical hubscommunicatively coupled to the cloud-based system in a surgical system,wherein the record links the unique identifier assigned to the surgicaldevice to a unique identifier assigned to the surgical hub.
 9. Thesurgical hub of claim 8, wherein the unique identifier comprises aunique serial number of the surgical device.
 10. The surgical hub ofclaim 8, wherein the instructions are further executable by theprocessor to: compare the decrypted unique identifier to a list ofauthorized identifiers; and permit use of the surgical device based on amatch of the decrypted unique identifier to an authorized identifier inthe list.
 11. The surgical hub of claim 10, wherein the instructions arefurther executable by the processor to: download the list of authorizedidentifiers from a cloud-based system communicatively coupled to aplurality of surgical hubs.
 12. The surgical hub of claim 8, whereinreceiving the encrypted identifier and the source ID from the surgicaldevice comprises: reading the encrypted identifier and the source IDfrom a memory device of the surgical device.
 13. The surgical hub ofclaim 8, wherein the instructions are further executable by theprocessor to: read usage data from a memory device of the coupledsurgical device; store at least a portion of the read usage data eachtime the surgical device is coupled to the surgical hub; compare theread usage data to previously stored usage data to identify adiscrepancy in the usage data; and prevent usage of the surgical devicewith the surgical hub based on an identified discrepancy.
 14. Thesurgical hub of claim 8, wherein the unique identifier assigned to thesurgical device comprises a serial number.
 15. The surgical hub of claim8, wherein the instructions are further executable by the processor to:store the record of the coupling of the surgical device and the surgicalhub as a genesis record, wherein the genesis record comprises atimestamp.
 16. The surgical hub of claim 15, wherein the instructionsare further executable by the processor to: store a new record for eachsubsequent coupling of the surgical device to the surgical hub, whereineach new record in a chain of records associated with the surgicaldevice comprises a cryptographic hash of a most recent record, a linkageof the unique identifier assigned to the surgical device to the uniqueidentifier assigned to the surgical hub, and a timestamp.
 17. Thesurgical hub of claim 16, wherein the instructions are furtherexecutable by the processor to: receive a record of a coupling of thesurgical device to one of the plurality of other surgical hubscommunicatively coupled to the cloud-based system; and store a newrecord for the coupling of the surgical device to the one of theplurality of other surgical hubs, wherein the new record in a chain ofrecords associated with the surgical device comprises a cryptographichash of a most recent record, a linkage of the unique identifierassigned to the surgical device to a unique identifier assigned to theone of the plurality of other surgical hubs, and a timestamp.
 18. Thesurgical hub of claim 17, wherein the instructions are furtherexecutable by the processor to: trace couplings of the surgical deviceto the surgical hub and the plurality of other surgical hubs in thesurgical system back to the genesis record.
 19. The surgical hub ofclaim 18, wherein the instructions are further executable by theprocessor to: analyze the traced couplings to determine whether pastusage of the surgical device contributed to or caused a failure event.